cyrilzakka/clinical-trials huggingface dataset:
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea

Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.


Eligibility Criteria:
Inclusion Criteria:

* Both genders;
* body mass index lower than 35Kg/m2;
* age between 18 and 65 years old;
* polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm.

Exclusion Criteria:

* Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content);
* temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp);
* excessive use of alcohol and psychoactive drugs;
* clinical, neurological or psychiatric decompensated diseases;
* others sleep diseases and previous obstructive sleep apnea treatment.
Development and Evaluation of Balance and Coordination Training System

This project aims to develop an interactive floor that will perceive the pressure, give the user visual (light) and auditory (signal) feedback, use a monitor that will guide the user with visual reporting, develop a software that enables the integration of the floor with the monitor, adjusts the degree of difficulty of education, records training, and objectively grades balance development, investigate the clinical effectiveness of the balance and coordination education system, in which hardware and software coexist, verify the validity and reliability of the developed system by evaluating its validity and reliability with proven tests.

In order to carry out daily life activities, independence of individuals should be insured. For this independence, it is necessary to have adequate balance and coordination. Without adequate balance and coordination, it is not possible to walk neither even to stand. Movement is the basic living unit of an organism. Balance and coordination are of great importance for smooth, fluid and convenient action. In the clinical settings individuals are given exercises in different ways to increase their balance and coordination to protect them from injuries and to gain their independence. Nowadays, in order to adapt to the future, technological devices that can analyze and improve balance and coordination are being developed. The adequacy of the devices or systems developed for this purpose is also discussed. Most of the systems available on market only provide balance training by moving the floor, while others aim to contribute to balance by stimulating joint proprioception with a vibrating ground. This project aims to develop equipments that will provide balance and coordination trainings to guide the user through visual, auditory and mechanical feedback, develop a software which will record, analyze and evaluate the trainings given while ensuring that this equipment works systematically, carry out clinical studies to investigate the effectiveness of this developed system in healthy people.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate
* Being healthy
* Being between 18-45 years of age

Exclusion Criteria:

* Presence of any neurological or orthopedic problems that may affect balance and coordination,
* Being pregnant,
* Any drug use that may affect balance and coordination,
* Any deformation in vertebrae or lower limbs,
* History of any surgery in the lower limbs in the preceding 1 year,
* Any nervous lesion, existing neurological diseases, sensory defects,
* Any hearing or visual problems
Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain

Sleep quantity and quality can be influenced by the type of mattress used. This study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep quality.

It is commonly observed that sleep in its quantity and quality is influenced by the type of mattress used at night. A recent study in patients with back pain showed that waterbeds and foam mattresses did influence back symptoms, function and sleep more positively than did a hard mattress. Pain improves with airbeds compared to regular innerspring mattresses. This study will analyze the effect of optically active particles mattress covers on sleep. The researcher is interested in learning if regular mattress or the study mattress cover (containing optically modified polyethylene terephthalate fiber mattress cover) is more useful in helping back pain and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

You are eligible to participate in this study if you:

1. have a clinical diagnosis of chronic lower back pain
2. have pain measured on the Visual Analogue scale
3. have sleep disturbances at night associated with chronic lower back pain
4. are 18 years or older
5. sign the written, informed consent form prior to the initiation of any study procedures
6. have an habitual bedtime between 8 P.M. and 12 A.M.
7. are on a stable pain management regime

Exclusion Criteria:

You are not eligible to participate in this study if you:

1. are unwilling or unable to comply with the protocol or scheduled appointments
2. are unable to understand the language in which the approved informed consent is written
3. have no pain measured on the Visual Analogue scale
4. are unable to walk, wheel chair bound or confined to bed
5. are deemed by the investigator to be unreliable to wear the actigraphy, to complete the sleep log, to use the provided mattress covers at the proper time, to come to the scheduled visits or to answer questions regarding the subject's condition or medication use
6. lack a mobile arm to which to attach an actigraphy.
7. are currently participate or participated in another clinical study within the past 30 days
8. demonstrate an unwillingness to comply with the maximum limit of two alcoholic drinks per day and only 1 alcoholic drink after 6:00 P.M. for the duration of the protocol
9. use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle
10. have any unstable medical condition as determined by the investigator, or any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol
Novel Regimens in COVID-19 Treatment

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019. Some studies demonstrated the efficacy of combined regimen of nitazoxanide and azithromycin or ivermectin and chloroquine.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COVID-19 infection

Exclusion Criteria:

* Allergy or contraindication to the drugs.
Troponin Elevation in Consecutive Patients With Hip Fracture

The aims of this study is to study the occurrence of the troponin elevations, ECG changes, and cardiac symptoms in unselected consecutive patients with hip fracture.

Followup will be carried out up to one year period.


Eligibility Criteria:
Inclusion Criterion:

* Hip fracture diagnosed in Turku Univeristy Hospital between October 2009 and May 2010

Exclusion Criterion:

* Patient refusal
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin

This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male volunteers.

This is a double-blind (neither physician or volunteer knows the name of the assigned study drug), placebo controlled (substance containing no medication), study in healthy, overweight or obese adult male volunteers. For each volunteer, the study consists of a screening phase (up to 30 days), a treatment phase during which volunteers will receive 4 study treatments in a randomized (study sequence assigned by chance) sequence (28 days), and a follow-up phase (10 days). During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be the effect of JNJ-38431055 and sitagliptin on glucagon like peptide-1 (GLP-1) levels. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 27.0 and 38.0 kg/m2 (inclusive)
* Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests
* Men must agree to use a double barrier method of birth control (e.g., condom for them and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication

Exclusion Criteria:

* History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
* Smoker or tobacco user within the past 6 months
* History of recent major surgery (within 6 months of study start)
* Positive test for alcohol and/or drugs of abuse
* Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
* Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements
Strategic Screening for Infectious Diseases (Tuberculosis, HIV, HBV, HCV) Amongst Migrants in France

To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for HIV and hepatitis) amongst a population of legal migrants during their mandatory medical check-up. This study aims for a global improvement of screening and care for migrants.

In France, the prevalence of infectious diseases such as tuberculosis, HIV/HBV/HCV is high amongst migrants originating from certain countries, hence the official guidelines recommending targeted testing. The rapid testing devices (TROD) give immediate results and reduce missed opportunities. However their use is not yet widespread and migrant populations remain insufficiently tested. Regarding the UNAIDS 90-90-90 goal, France is failing the screening part of the treatment cascade, while 90% of patients are treated and have undetectable viral load. Risk scores based on the best known risk factors for these infections (HIV/HBV/HCV) have previously been developed. They have helped build a pilot of a new unique questionnaire: TROD screen. An electronic survey, called TB screen, was designed to screen for tuberculosis amongst asylum seekers in Switzerland and validated. This survey enables to detect signs of active tuberculosis and may replace the use of pulmonary radiography, thus reducing exposure to X-rays.

It is a prospective multi-centric observational study validating screening tests for HIV/HBV/HCV in two phases:

* Phase 1: a risk score will be validated, including a qualitative study analyzing its acceptability
* Phase 2: its performance will be compared with that of a screening targeted based on the country of origin The phase 1 and phase 2 will include respectively 10.000 and 5000 participants.

For tuberculosis, the efficacy of the improved version of TB screen will be compared with a systematic radiography.

Participation to this study will be voluntary and independent from the delivery of a residence permit. Participants will be informed of it and will systematically receive information about prevention of those infectious diseases.

Eligibility Criteria:
Inclusion Criteria:

* Migrants undergoing the routine medical visit
* Giving informed consent (oral consent)

Exclusion Criteria:

* Asylum seekers
* Persons not understanding the questionnaire
* Persons aware of their HIV, HBV or HCV positive status
Node Negative, Invasive Breast Cancer Single Fraction IOERT

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

See points VIII inclusion/exclusion criteria

Operation:

* Lumpectomy, steninal node biopsy
* IOeRT

After Surgery:

* Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
* Chemotherapy (if indicated)
* Hormone therapy (if indicated)

Follow-Up

* Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.
* Assessements of acute toxicity according to CTC-toxicity scoring system
* Assessments of late toxicity according to LENT-SOMA scoring systems
* Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.

Eligibility Criteria:
Inclusion Criteria:

* Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
* Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
* Post-menopausal women age \> 60, defined as women who have experienced no menstrual period in the past 12 months.
* BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\]
* Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
* Grade 1, 2 acceptable
* Associated LCIS is allowed
* Estrogen receptor (ER) status of positive
* Negative margins at ink on gross pathologic examination
* Patient is node-negative, defined as N0 (i-) or N0 (i+)
* Patient must be deemed functionally and mentally competent to understand and sign the informed consent

Exclusion Criteria:

* Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years
* Immuno-compromised status
* Pregnancy
* Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
* Breast cancer that involves the skin or chest wall, locally advanced breast cancer
* Pure DCIS, all grades
* Invasive lobular carcinoma
* Evidence of lymphovascular invasion (LVI)
* Invasive carcinoma with extensive intraductal component (EIC)
* Neoadjuvant chemotherapy indicated
* Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
* Not eligible for breast conserving management, i.e., prior whole breast radiation therapy
* Estrogen receptor negative
* Her2 positive
* Grade 3
Predictive Factors for the Results of Epiphysiodesis in Limb Length Discrepancy

Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery.

The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care.

The patients will be distributed in two groups : "fulfilled contract" and "failed contract" The differences between the two groups will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with limb length discrepancy who had epiphysiodesis surgery

Exclusion Criteria:

* Missing x-rays
* missing data
* bone growth not achieved
A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.

The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.


Eligibility Criteria:
Inclusion Criteria:

* History of allergic conjunctivitis to ragweed for at least one year
* Positive skin prick test to ragweed pollen within 12 months prior to visit 1
* BCVA of at leat 20/400

Exclusion Criteria:

* Structural lid abnormalities (ectropion, entropion)
* Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
* Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
* History of ophthalmic abnormality, including a history of dry eye
* Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
* History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
* presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
* Currently on any chronic ocular topical medications
* Use of topical or systemic ocular medications during the study period
* History of complications, adverse events, trauma or disease in the nasolacrimal area
* History of symptomatic epiphoria
Alemtuzumab for ANCA Associated Refractory Vasculitis

Overview:

This open label, randomized, multi-centre study will enroll and treat 24 patients with refractory AAV.

Aims:

To determine the clinical response and severe adverse event rates associated with alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV).

Hypothesis:

Treatment with alemtuzumab induces sustained remission in AAV and will reduce immunosuppressive and steroid exposure.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of AAV, according to a standardized definition
2. Active vasculitis with at least one severe or three non severe items of BVAS/WG activity (equivalent to BVAS/WG\>3)
3. Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone for at least 3 months.

Exclusion Criteria:

1. Age less than 18 or greater than 60 years
2. Creatinine \> 150μmol/l (1.7mg/dl)
3. Total white count \< 4x109/l or lymphocyte count \< 0.5x109/l, or IgG \< 5g/L, or neutrophil count \< 1.5x109/l.
4. Severe lung haemorrhage with hypoxia (\<85% on room air)
5. Severe gastrointestinal, central nervous system or cardiac vasculitis
6. Previous therapy with:

   1. Alemtuzumab at any time
   2. IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in past three months
   3. Rituximab within the past 6 months
7. Intensive care unit requirement
8. Active infection with HIV, hepatitis B or hepatitis C or other infection requiring parenteral or long-term oral antibiotics
9. History of ITP or platelet count at screening below 50,000 x 106/l
10. Pregnancy or inadequate contraception in pre-menopausal women
11. Breast feeding
12. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
13. Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia
14. Any previous or current history of malignancy (other than resected basal cell carcinoma)
Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China

To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect) by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

This study is prospective to identify biomarkers to resistant to afatinib，gefitinib and erlotinib in non-small cell lung cancer patients. Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with non-small cell lung cancer and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years,both male and female
* Histologically confirmed patients with pulmonary adenocarcinoma (Stage I-IV)
* ECOG 0-2
* Patients with enough paraffin tissue specimens or fresh tissue for detection
* Quality of the DNA extracted from the tissue samples ensures that the DNA can be used in DNA sequencing
* Subjects who provide detailed clinical and follow-up information

Exclusion Criteria:

* Patients with other tumors
* Patients suffering from other serious diseases like infectious diseases (viral hepatitis, HIV,etc)
* Pregnant women shall be excluded