cyrilzakka/clinical-trials huggingface dataset:
Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function

This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment.

52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group.

Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.

This prospective observational non-randomized clinical study aims to assess the effect of use MAD on masticatory performance. 52 subjects diagnosed with OSA will participate in this study divided into two different groups: 26 treated with MAD and 26 treated with CPAP. Data collection will be carried out before the start of treatment of the two modalities and at 3, 6, 12 and 24 months after starting the treatment. The intervention of the study will be based on execute chewing tests to evaluate masticatory performance from artificial food. Other aspects of matsticatory function would be also explored like subjective masticatory performance and jaw function limitation, dental position and occlusion, bite force or dental mobility. Artificial food tests will evaluate masticatory performance in comminute and mixing ability to determine the degree of reduction in masticatory performance produced by the use of MAD after 3 months of treatment. The main variable to be studied will be the median particle size of silicone tablets from Optozeta's test. This test is based on chewing 2 grams of silicone tablets inside a latex bag in order to evaluate their degree of comminution. The greater of grinded silicone, the greater of chewing performance. Another masticatory performance test will also be carried out is evaluation subject's mixing capacity with a two-colour chewing gum test. Degree of mixing of two colours of the gum will be checked after 40 chewing cycles. The more uniformity of the colour obtained, the more mixing ability the subject will demonstrate. A CPAP group control will be used, which will additionally allows us to know if this treatment has effects on dental position, occlusion and masticatory performance.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with OSA by polisomnography (IAH\>15).

Exclusion Criteria:

* Be treated with MAD or CPAP during more than 3 months in the lasts 5 years.
Follow-up of GANI_MED Cardio Cohorts

Follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized Medicine). Standardized protocols will be used for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. Comparisons with the general background population will be performed.

5-year follow-up of two hospital-based patient cohorts (heart failure, metabolic comorbidities in CVD), recruited at baseline by the GANI_MED-project (Greifswald Approach to Individualized Medicine). Subjects will be comprehensively phenotypes using standardized protocols for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. A multi-omics based biomarker assessment including genome-wide genotyping, transcriptome, metabolome, and proteome analyses complements the multi-level approach of GANI_MED. Comparisons with the general background population as characterized by the Study of Health in Pomerania (SHIP) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Participation in baseline examination of GANI_MED cohorts (heart failure, metabolic risk)

Exclusion Criteria:

* none
Inhaled NO for the Treatment of Viral Pneumonia in Adults

The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Patients (male and female) admitted to the hospital for clinical diagnosis of viral pneumonia including COVID-19 patients that have a positive nasal swab.
* Age 18 to 80 years
* Female subjects must be willing to use medically acceptable contraception from screening to Day 30 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent).
* Ability to understand and comply with study requirements.
* Signed informed consent by subject

Exclusion Criteria:

* Patients with pneumonia with two or more of the following:

  1. WBC of more than 15,000
  2. Lobar pneumonia
  3. Pleural effusion
* Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
* Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
* Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction (LVEF \<40%) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
* Use of an investigational drug during the last 30 days prior enrollment
* Methemoglobin level \>3% at screening
* Patients on chronic (over two weeks of treatment) systemic steroids (any formulation, excluding Dexamethasone or Prednisone) within 30 days prior to enrollment.
* History of daily, continuous oxygen supplementation
* Patients with BMI greater than or equal to 40
* Patients with clinically significant anemia, e.g., Hb \<10.0 and/or thrombocytopenia, e.g., Platelets \<75.
* Smokers who are unwilling to refrain from smoking during hospitalization
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data, e.g., known or suspected thalassemia, sickle cell disease or other diseases associated with poor oxygen carrying capacity.
* The subject is identified by the investigator as being unable or unwilling to perform study procedures.
PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma

Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied.

Alteration of neuro-cognitive function induced by chemotherapy has been extensively documented in breast carcinoma patients. These modifications consist in the decrease of memory, intellectual capacity, speed analysis, and represent a real limitation for patients, sometimes durable. Aggressive lymphomas (diffuse large B cell lymphomas/DLBCL) represent a common disease, the standard being Rituximab-Cyclophosphamide-Doxorubicine-Vincristine-Prednisone (RCHOP) regiment which contains, as for breast cancer patients, anthracyclines. However, very little is known about the incidence and severity of cognitive function alteration in these patients. The occurrence of such complications should also be facilitated because of frail cognitive states due to age and co-morbidity. Cognitive function alteration is usually measured by neuropsychological tests (NPT) which are easy to handle and sensitive, but could lack specificity, in the context of general degradation which is often observed in hematological patients.

Positron emission tomography with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied. In our center, the investigators have already described glucidic hypometabolism in several brain territories associated with Alzheimer's disease and other dementia. Moreover, uptake quantification and topography are useful markers for determining the type of the disease and progression. PET-FDG received very little attention for the detection of chemotherapy-induced brain damages.

Eligibility Criteria:
Inclusion Criteria:

* histologically documented DLBCL
* previously untreated
* with International Prognostic Index (IPI) 0 or 1, or 2 without general state alteration (OMS≤2)
* submitted to RCHOP regimen (according to GELA's standard protocol)
* normal pre-treatment brain CT scan
* able to give informed consent
* speaking well French language
* benefiting from general medical insurance
* registered in the national listing of patients for biomedical research.

Exclusion Criteria:

* IPI \> or =3
* medical history of another cancer, or psychiatric or pre-dementia disorder, or convulsion
* barbituric regular use which can't be stop
* human immunodeficiency virus (HIV) patients
* unstable diabetes mellitus
* pregnancy
Functional Implications of Arthroscopic Iliopsoas Release

The purpose of this study is to investigate the functional effects of arthroscopic iliopsoas release. To complete this aim, we will recruit patients who have undergone arthroscopic iliopsoas release by Dr. Aoki. Each subjects contralateral nonoperative hip will serve as their own control. To delineate the effects of arthroscopic surgery alone from those resulting from iliopsoas release in addition to arthroscopic surgery, we will recruit a second control group consisting of patients who have undergone arthroscopic surgery by Dr. Aoki without iliopsoas release.

For both hips of each subject, we will:

* Quantify the muscle volume of the iliopsoas muscle with MRI.
* Quantify hip flexion strength with isokinetic dynamometry.
* Quantify patient function and satisfaction with functional outcome surveys.

This data will allow us to test the following hypotheses:

* Compared to the non-operative hip, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
* Compared to hips undergoing arthroscopic surgery without iliopsoas release, hips undergoing arthroscopic iliopsoas release have decreased iliopsoas muscle volume and hip flexion strength.
* Patient function and satisfaction positively correlates to muscle bulk and strength.


Eligibility Criteria:
Inclusion Criteria:

* All subjects will be greater than 18 years of age.
* We will recruit 18 subjects who have undergone arthroscopic iliopsoas release by Dr. Aoki.
* We will recruit 18 additional subjects that had hip arthroscopy with Dr. Aoki without iliopsoas release to serve as a control group.

Exclusion Criteria:

* As the nonoperative contralateral hip will serve as a control to the operative hip, we will exclude patients for this study who have undergone bilateral procedures.
* We will exclude any patients who are not comfortable with the MRI scan, stationary bike or strength testing.
Biomakers in Tissue Samples From Patients With Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck Previously Treated With Cisplatin With or Without Cetuximab

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab.

OBJECTIVES:

* To investigate the association between ERCC1 expression and clinical outcomes (response rate, progression-free survival, and overall survival) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who received cisplatin with versus without cetuximab on clinical trial ECOG-E5397.

OUTLINE: Archived tumor tissue samples are analyzed for ERCC1 expression by IHC. ERCC1 levels (low or high) are assessed by an H-score and AQUA, a quantitative IHC analysis. Each patient's ERCC1 level result is then compared with the patient's clinical outcome.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of squamous cell carcinoma of the head and neck

  * Recurrent and/or metastatic disease
* Received cisplatin with or without cetuximab on clinical trial ECOG-E5397
* Slides and blocks of tumor specimens available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Maximum Oxygen Uptake in ACL-injured Professional Soccer Players

Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer players and after a six-month period of post-operative rehabilitation, compared to a control group of healthy professional soccer players.

The anterior cruciate ligament (ACL) rupture is considered a major injury and may affect the career of professional soccer players. Surgical ACL reconstruction is often required to treat the resulting knee instability. Although ACL reconstruction is considered a successful procedure in restoring knee stability, literature shows that only 55% of the participants return to competitive sports participation after surgery. Soccer players need technical, tactical and physical skills to succeed, such as good knee function and aerobic capacity. Our purpose is to evaluate maximum oxygen uptake (VO2max) in ACL-injured professional soccer players and after a six-month period of post-operative rehabilitation, compared to a control group of healthy professional soccer players.

Eligibility Criteria:
Inclusion Criteria:

* ACL injury
* professional soccer player
* adult
* male

Exclusion Criteria:

* Multiple ligament injury
* knee effusion
* unable to perform the examination on the treadmill
* ACL reconstruction failure
* reoperation due to any cause during the follow-up period
* goalkeeper
Ankle Kinesio Taping vs Mulligan's Mobilization With Movement

The aim of the study is to compare the effects of Kinesio taping and Mulligan's mobilization with movement technique on balance, muscle strength and flexibility in healthy ankles . Patients will randomly be divided into 4 groups: Kinesio taping (KT) group, sham Kinesio taping (SKT) group, Mulligan's mobilization with movement (MWM) group and sham mobilization with movement (SMWM) group . Kinesiotape will be applied both ankles as "Correction technique" in KT group, 'Posterolateral glide mobilization with movement' will be applied 10 times to both ankles in MWM group. The evaluations will be repeated after waiting 45 minutes to reveal the effects of Kinesio taping and Mulligan mobilization with movement.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35
* Healthy individuals
* Able to read, write and understand Turkish
* willing and able to attend study

Exclusion Criteria:

* Any neurological, musculoskeletal or vascular disease in any of the lower extremity.
* Previous history of surgery in any of the lower extremity.
* Mental and cognitive disorders that would seriously affect cooperation
Pulmonary Embolism Registry

Acute Pulmonary Embolism (PE) is the most serious clinical presentation of venous thromboembolism (VTE), a leading cause of cardiovascular mortality, exceeded only by stroke and myocardial infarction. Chronic thromboembolic pulmonary hypertension (CTEPH) is the most severe chronic form of CTED and it occurs in 2-4% of patients after acute PE.

In Portugal little is known about PE epidemiology and its outcomes, including complications like CTED. The main goal of this study is, therefore, to understand PE epidemiology and complications in the northern region of Portugal. This information can enable the organization of a structured health care network that can potentially benefit all PE patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute symptomatic or asymptomatic PE,
* Age \>18 years,
* Availability of a minimum data set for PE and a minimum of 3-months follow-up for the primary objective and 36-months for the secondary one. Except for patients who died prior to the 3 or 36 months follow-up.

Exclusion Criteria:

* Enrolment of the patient in any treatment trial in a blinded fashion,
* Lack or withdrawal of patient´s consent.
Lung Disease Associated With Rheumatoid Arthritis

Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.

Patients participating in this study will undergo a series of tests and examinations before and throughout the study. The tests include blood and urine tests, electrical measures of heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests, exercise tests, and fiberoptic bronchoscopy.

The goals of this study are to:

1. Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,
2. Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,
3. Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and
4. Learn more about the factors that contribute to the development or progression fibrotic lung disease....

Pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology remains uncertain. Although the clinical course of many individuals with this disorder can mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. It is the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic, radiologic, and biochemical markers that predict the development or progression of fibrotic lung disease.

Eligibility Criteria:
* INCLUSION CRITERIA:

Non-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of age or older with any of the following:

Rheumatoid arthritis with biopsy-proven pulmonary fibrosis or;

Rheumatoid arthritis only, or;

Biopsy-proven idiopathic pulmonary fibrosis.

EXCLUSION CRITERIA:

Forced expiratory volume in one second (FEV1) less than 1L.

Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).

Chronic cardiopulmonary disorders other than pulmonary fibrosis.

Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).

Non-rheumatoid arthritis.

Viral infections associated with pulmonary fibrosis (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).

Uncorrectable bleeding diathesis.

Pregnancy or lactation.
MPI Predicts Outcome of CRC Elderly Patients (MPI=MULTIDIMENSIONAL PROGNOSTIC INDEX; CRC=COLORECTAL CANCER)

Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The importance of this report is that MPI-score resulted strongly associated with major complications and it was a primary component of an individual prediction model.

Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The MPI (multidimensional prognostic index)-score resulted strongly associated with major complications. also, it was a primary component of an individual prediction model (LASSO model).

Eligibility Criteria:
Inclusion Criteria:

All CRC patients aged ≥75 years, who were scheduled for elective surgery and able to express their consent to treatment, were considered.

Exclusion Criteria: emergency surgery; patients aged \<75 years; patients unable to sign informed consent.
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

The primary objectives of this study are to describe the efficacy of:

1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
2. 12-week treatment of SOF/LED for all other HCV-6 populations

The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥18 years
2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
3. Selected to start on treatment by their treating providers
4. Willing and able to provide informed consent
5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Lactating females must agree to discontinue nursing before the study drug is administered

Exclusion Criteria:

1. Previous recipient of a liver transplant
2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
A Study Of Tasocitinib In Dry Eye Subjects

This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and objective clinical endpoints will be measured for a duration of 12-week treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 years or older at time of consent
* Diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at least 6 months, Schirmer test without anesthesia: =\>1 mm and =\<7 mm, sum of corneal fluorescein staining score of =\>4 (NEI Scale), and subject grading total score of =\> 23 on the OSDI

Exclusion Criteria:

* Planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of the Screening visit or during study
* Ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following: abnormal lid function, lid position, or blink rate, that in the opinion of the investigator is clinically significant, history of herpetic keratopathy
* Lacrimal punctal occlusion (plugs or cautery) within 2 months of the Screening visit
* Contact lens wear within 2 weeks of the Screening visit and/or during study participation.