cyrilzakka/clinical-trials huggingface dataset:
Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment

The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period.

A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.

The null hypotheses are:

* that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer
* that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer
* that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment

The study is conducted at the Orthodontic Clinic, Gävle, Sweden and consists of 104 patients. All patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. The patients are randomized into two groups with 52 patients in each group (Group A: cuspid-to-cuspid retainer, Group B: Essix retainer).

Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups.

At the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with fixed appliances in both the maxilla and the mandible

Exclusion Criteria:

* Rapid Maxillary Expansion (RME) for patients with severe transversal malocclusion
* Treatment with segmented appliances
* Patients with craniofacial anomalies and patients requiring orthognatic surgery
* Patients with missing mandibular incisor
cKIT, BRAF/NRAS Mutations in Advanced Melanoma : Clinical Outcome in Response to Tyrosine-kinase Inhibitors - KitMel Project

Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of cancer death in young patients. Until now, available therapies were few and unreliable, but recent understanding of melanomas' molecular pathways has improve their classification and new clinical strategies have been proposed.

Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex with four exons being affected leading to different mutations, which incidence and biological impact are less documented.

BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets. Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations modulate differently c-Kit function and the response to targeted therapies.

Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to identify the most frequent mutations present in our population to propose appropriate screening test and adapt the therapy.

Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in codon 12, 13 and 61 (Pyrosequencing).

Expected Results:

Taken together, the investigators anticipate that the present genetic analysis of the tumours from patients with advanced melanoma will first document the type and frequency of cKit mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually exclusive and document their repartition in the melanomas sub-types. Finally this study will clue researchers in to how well patients will respond to a therapy that targets the growth-promoting proteins BRAF/NRAS and cKIT.


Eligibility Criteria:
Inclusion Criteria:

* melanoma
* white caucasian population
Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.

rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Clinical diagnosis of major depressive disorder (DSM-IV)
* HDRS-17 items \> 20
* Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)

Exclusion Criteria:

* I or II bipolar disorder
* Psychotic features
* Failure of one previous venlafaxine treatment
* Addiction comorbidity or schizophrenia comorbidity
* Involuntary hospitalization
* Seizures history
* Pregnancy or breastfeeding
* Somatic comorbidity able to impact on cognitive functions
Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment

Proglumide is an oral cholecystokinin (CCK) receptor antagonist that has been shown in non-clinical studies to reverse hepatic fibrosis and decrease the incidence of hepatocellular carcinoma (HCC). Because of these potential beneficial properties, proglumide may be useful in decreasing the fibrosis and risk for HCC in those with cirrhosis. Although proglumide is safe in those with normal hepatic function, the pharmacokinetics have not been established in those that are hepatic impaired. The purpose of this study is to analyze proglumide blood levels and excretion in subjects with cirrhosis compared to health controls.

The purpose of this study is to measure blood levels of proglumide after a single oral dose (400 mg) over a period of time and compare the blood levels to those with normal hepatic function (N=4) to determine if there is delayed metabolism and clearance of proglumide in those with hepatic impairment (HI) (N=8). Eligible subjects will provide a baseline blood and urine sample prior to ingesting proglumide 400 mg po. Blood will be collected from an intravenous catheter after ingestion at the following intervals: 1 hr, 3 hrs, 5 hrs, 7 hrs and 24 hr (± 4-5 hours). After 3 hrs and 5 hrs subjects will provide a urine sample. Samples will be analyzed by Mass Spectometry. Proglumide blood and urine levels in ng/ml will be plotted over time and the Cmax (peak plasma concentration), Tmax (time to reach Cmax) and T1/2 (elimination half time) calculated for each subject and compared to that of 4 healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis previously confirmed by one of the following: Liver biopsy, FibroScan, FibroSure, MR-Elastography, or nodular liver on radiographic imaging like CT or MRI. Child-Pugh classification A (N=4) and Child-Pugh classification B (N=4)

Exclusion Criteria:

* Those that are Child-Pugh classification C cirrhosis
* gastrointestinal bleeding from esophageal varices within 6 months
* Chronic kidney disease with Estimated glomerular filtration rate (eGFR of \< 90 mL/min/1.73m2)
* hepatic encephalopathy
* those that have had an organ transplant
* active hepatitis C, active hepatitis B, and those with HIV disease

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers)
  * Pregnant women
  * Prisoners
Machine Vision Based MDS-UPDRS III Machine Rating

The Movement Disorders Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III (MDS-UPDRS III) is the primary assessment method for motor symptoms in Parkinson's disease patients. Currently, movement disorder specialists conduct semi-quantitative scoring, which entails limitations such as subjectivity, weak sensitivity, and a limited number of professional physicians. This study, based on machine vision, establishes gold standard labels according to expert scoring. By using machine learning, we develop a machine rating model and compare the model's performance with gold standard rating and general clinical rating to investigate the accuracy of machine vision-based MDS-UPDRS III machine rating.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for Parkinsonism established by the International Movement Disorder Society: having bradykinesia, and meeting at least one of the two criteria for resting tremor or muscle rigidity
* 20 to 80 years old
* Good compliance, voluntarily joining the study, and able to sign an informed consent form or have it signed by a legal representative

Exclusion Criteria:

* Significant cognitive impairment (MMSE ≤ 23)
* Unable to sign written informed consent or unable to complete the trial due to other reasons
* Other situations in which the researcher deems the participant unsuitable for this study
* Participation in other clinical trials
Tuberoplasty Versus Balloon Spacer

The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.


Eligibility Criteria:
Inclusion Criteria:

* Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus.
* No involvement of the subscapularis.
* Centered humeral head on X-ray examination.
* Primary complaint of pain.
* History of prior surgery, including failed rotator cuff repair.

Exclusion Criteria:

* Involvement of the subscapularis.
* Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph.
* Rotator cuff deemed repairable at the time of surgery.
* Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65
Dose Response of Ketorolac in Knee Arthroscopy

Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.

Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.

Eligibility Criteria:
Population: Patients scheduled for outpatient knee arthroscopy under general anesthesia with ASA physical status I-III ages 18-65 years old. All subjects will receive informed consent. Subjects will not be eligible to participate if they cannot provide informed consent. Non-English speaking patients will not be included due to the limited time and availability of translators.

Inclusion Criteria:

1. Ability to consent and desire to participate in study
2. Outpatient knee arthroscopy with Dr. C. David Geier
3. ASA physical status I-III
4. 18-65 years old
5. Over 50 kg (110 pounds)
6. General anesthesia

Exclusion Criteria

1. Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
2. Allergy to propofol, fentanyl or hydromorphone.
3. Any chronic painful conditions requiring opioid use for over the last 6 months
4. Emergency surgery
5. Altered mental status (not oriented to place, person or time)
6. Pregnant or lactating patients
7. Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
8. Non-English speaking
9. Patient refusal to study
10. Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)
Epidemiological Data on Mast Cell Pathologies in France

Mast cell disorders constitute a heterogeneous group of diseases, including :

* mastocytosis, i.e. cutaneous, indolent and severe forms of the disease, such as aggressive mastocytosis and mast cell leukemia) ;
* mast cell-associated diseases such as mast cell activation syndrome (idiopathic, secondary or clonal), affecting both children and adults.

No epidemiological data are currently available in France.

In France, medical care of mast cell disorders is mainly provided by a rare disease network (CEREMAST), whose CRMR is located at the Necker Enfants Malades hospital in Paris. A total of 20 centers are located throughout France.

Our aim is to use this network to study patients suffering from these diseases. The overall aim of the study is to improve the understanding, diagnosis, prognosis, recognition and management of patients with mastocytosis.


Eligibility Criteria:
Inclusion Criteria:

1. Children from birth and adults of any age
2. With one of the following mast cell diseases:

   * Mastocytoses (cutaneous, systemic and sarcomas) Defined according to the WHO 2016 classification
   * Mast cell activation syndromes (idiopathic, secondary and clonal)
   * Other mast cell activation disorders (MCAD-NOS), Defined according to the Vienna classification
   * Pre-mastocytosis or MMC (1 to 2 criteria according to WHO 2016 classification).
3. Managed in France in a rare disease reference, constitutive or competence center (CEREMAST) with DGOS labelization.

Exclusion Criteria:

1. Opposition of the patient or his/her parents to participation in the study.
Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.

This study aims to assess the impact of myopia in childhood and its long-term complications in adulthood on health-related Quality of Life (HRQoL), providing valuable data for cost-effectiveness models. It will gather country-specific information on healthcare resource utilization, including treatment costs, access to care, and reimbursement policies. In addition, the study will examine how myopia and its treatments affect daily activities and evaluate treatment satisfaction. No data on the efficacy of myopia treatments is collected in this study, and neither is the occurrence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Parents (or other proxy) of children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) defined by their spherical equivalent (SER): Low myopia is from -0.5 D (inclusive) to -3.0 D (inclusive), Moderate myopia is from -3.0 D to -6.0 D (inclusive) and High myopia is \<-6.0 D.
* Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.
* Patients where myopia is a known or likely contributing factor to the complication.

Exclusion Criteria:

* Parents (or other proxy) of children aged 4 years and below.
* Patients where the complication is likely unrelated to myopia (e.g., cataract caused by diabetes) will be excluded
The Effect of Opioid-Free Anesthesia in TMJ Surgery

This study aims is to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing oral and maxillofacial surgery (OMF) temporomandibular joint (TMJ) surgery.

This study will enroll 60 patients undergoing TMJ surgery at Massachusetts General Hospital. Anesthetic care will be standardized according to current institutional standards of care. Intraoperative clinicians will not be blinded to group assignment. Patients will be randomized to one of two groups:

* Group 1 - Opioid-free Anesthesia Patients: Patients who are not receiving opioids but the total intravenous anesthetic during surgery.
* Group 2 - Standard Anesthesia Patients: Patients who undergo the standard of care and receive opioids as part of their anesthetic regimen.

Both groups employ strategies that are routinely used as part of standard clinical practice for TMJ surgery. Patients will otherwise receive the institutional standards of care for their surgical procedure and perioperative care.

Following intraoperative drug administration patients will be followed until discharge from the PACU to assess study endpoints while in the hospital. At the time of discharge from the PACU, members of the study team will ask the patient to compete a brief survey on their satisfaction with pain management.

Patients in this study will be anticipated to be discharged the same day as the surgical procedure. At the time of hospital or PACU discharge, the patient will be provided with a Medication Diary. This will be used to record pain medication administration in the first 48 hours after surgery, as well as any pain or complication they might experience at home.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 (inclusive)
* Scheduled for TMJ surgery (including both unilateral and bilateral procedures)
* Planned arthroscopic surgical procedure
* Preoperative plan to discharge the same day

Exclusion Criteria:

* Inability to provide written informed consent
* Pregnant patients
* Open TMJ Surgeries
* Planned overnight admission
* Mental status disorder or patient who are unable to communicate
Precision Pharmacotherapy Smoking Cessation Program

The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.

Promising new evidence suggests that applying a precision pharmacotherapy approach based on the nicotine metabolite ration (NMR), a commercially available, genetically-informed marker of nicotine metabolism rate can significantly improve cessation outcomes. Evidence from multiple independent studies, including a recent randomized clinical trial (RCT), demonstrates that matching slow metabolizers of nicotine with the nicotine patch and fast metabolizers of nicotine with varenicline can maximize treatment response and minimize side effects. While encouraging, a critical gap in knowledge is how to best translate a precision pharmacotherapy approach into a hospital-based smoking cessation intervention and improve cessation rates for underserved smokers. Preliminary data suggest that personalized treatment recommendations may increase smoking cessation medication uptake and effectiveness. Thus, the scientific premise of this application is that integrating a precision pharmacotherapy approach into a hospital-based smoking cessation program will increase medication uptake and effectiveness, with particular relevance for smokers from underserved communities.

Eligibility Criteria:
Inclusion Criteria:

* current smoker (5+ cigarettes/day)
* patient at the Helen F. Graham Cancer Center \& Research Institute (ChristianaCare) lung/thoracic clinic

Exclusion Criteria:

* use of non-cigarette tobacco products or smoking cessation treatment
* psychiatric or other medical contraindications to receiving smoking cessation medication
* no telephone
* medical instability
* inability to communicate in English
* unable to consent due to mental status
* estimated life expectancy of \<6 months
* not a Delaware resident
* pregnancy
Carotid Atherosclerosis and Vascular Events in People With Diabetes

Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 ans
* Diabetes
* Carotid duplex ultrasonography in 2012

Exclusion Criteria:

* None
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
* ECOG performance status 0-2 with expected more than 6 months of survival time
* Willingness to comply with required protocols and give permission to use the data for clinical research and products development

Exclusion Criteria:

* Patients have other primary cancers
* Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
* Patients failed in either plasma or tissue sample QC