cyrilzakka/clinical-trials huggingface dataset:
Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. The study includes retrospective data collection from the medical records and data collection from one prospective study visit with a clinical examination.The primary objective is to evaluate success. Success is defined as that the study implant and abutment are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant tissues are reported during the study.


Eligibility Criteria:
Inclusion Criteria:

* Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s):

  * during 2010, 2011, 2012 or 2013
  * made of titanium or gold-shaded titanium
  * connected to implants from: BIOMET 3i; Straumann; Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System).
* Being at least 18 years at day of enrollment
* Having signed and dated the informed consent form

Exclusion Criteria:

* Unable to come for study visit
* Not willing to participate in the study or not able to understand the content of the study.
* Involvement in the planning and conduct of the study (applies to both DENTSPLY Implants staff and staff at the study site).
* Simultaneous participation in another clinical study that may interfere with the present study
Quetiapine in Social Anxiety Disorder

The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.

This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

Eligibility Criteria:
Inclusion Criteria:

* adult outpatients 18-65 years of age
* primary diagnosis of social anxiety disorder, using DSM-IV criteria
* minimum CGI severity score of 4 at baseline
* minimum BSPS score of 20 at baseline
* written informed consent
* negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

* current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
* any current primary anxiety disorder other than SAD or current primary depression
* history of substance abuse or dependence with the last 6 months
* suicide risk or serious suicide attempt within the last year
* clinically significant medical condition or laboratory abnormality
* women of childbearing potential who are unwilling to practice an acceptable method of contraception
* concomitant medication use for psychotropic purposes
* history of hypersensitivity to quetiapine
Screening for Psychosocial Risk in Flemish Families of a Child With Cancer

The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening for psychosocial risk factors in families of a child with cancer. This study want to investigate the validation and evaluation of the clinical value of the Flemish translation of the psychosocial assessment tool

Psychosocial support of children having a diagnosis of cancer and their families is a crucial aspect of a qualitative treatment. Assessment of psychosocial needs is a first step in order to provide better and preventive psychosocial support. In Flanders, no instrument for screening of psychosocial needs is available. The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening for psychosocial risk factors in families of a child with cancer. This study want to investigate the validation and evaluation of the clinical value of the Flemish translation of the PAT. Two large Flemish pediatric oncology centers will participate: University hospital Ghent (UZGent) and the University hospital in Leuven (UZLeuven). During a time period of 2.5 years families in which a child received a new diagnosis of a pediatric cancer will be invited to participate in this study. All subscales of the PAT will be validated by the use of standardized parent questionnaires measuring similar constructs: Inventory Social Reliance, Strengths and Difficulties Questionnaire, Hospital Anxiety and Depression Scale, Parenting Stress Index-short version and illness cognitions questionnaire, parent version. The usability of the PAT will be evaluated with the PAT-Netherlands Usability questionnaire. The clinical value will be evaluated by comparing the clinical judgment of psychosocial risk by the psychosocial team members of both centers with the scores on the PAT.

The proposed project is an important step to ameliorate psychosocial support in families with a child with a diagnosis of cancer in Flemish pediatric oncological centers.

Eligibility Criteria:
Inclusion Criteria:

* parents of all children and adolescents from 0-18 years that are diagnosed with cancer

Exclusion Criteria:

* no knowledge of Dutch language
Technical Development for Pediatric Cardiovascular MRI

This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate pediatric patients with cardiovascular disease,congenital heart disease in patients of all ages, fetuses undergoing clinically indicated MR imaging.

The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease, congenital heart disease, fetal cardiac structure, function, and physiology, and other fetal organ analysis. Individuals referred to Children's National Medical Center for a clinically indicated cardiac MRI or cardiac catheterization by their primary referring cardiologist or obstetrician, and who are enrolled in this study may also undergo additional research imaging.

Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

Clinically indicated exams

1. Patients who are undergoing a medically indicated MRI scan or cardiac catheterization procedure
2. Patients who are medically judged to have no contraindications to MRI scan
3. Age inclusion: infant to adult
4. Written informed consent and assent, when applicable

Volunteers

1. Written informed consent from any normal volunteer 8 years of age or older for a noncontrast, nonsedated cardiac MRI
2. Normal adult volunteer to undergo cardiac MRI with contrast agent

Fetal exams

1. Age inclusion:18 years and older
2. Second or third trimester (greater than 13 weeks)

Exclusion Criteria:

1. All patients who are medically judged to have contraindication(s) to MRI scanning will be excluded. Contraindications include implanted metal devices which are contraindicated for MRI scanning:

   * Central nervous system aneurysm clips;
   * Implanted neural stimulator;
   * Implanted cardiac pacemaker or defibrillator;
   * Cochlear implant;
   * Ocular foreign body (e.g. metal shavings);
   * Implanted Insulin pump;
   * Metal shrapnel or bullet.
2. Exclusion criteria for Bicycle Stress MRI

   * Myocardial infarction within 24 hours
   * Active myocarditis
   * Uncontrolled heart failure
   * Severe left ventricular outflow tract obstruction
3. Exclusion Criteria for adult volunteers undergoing MRI with administration of contrast agent:

   * 60 years of age or older
   * Renal Disease; Glomerular Filtration rate (eGFR \< 30 ml/min/1.73 m2) will be determined by a simple blood test done at the bedside
   * Use of diuretics
   * Diagnosis of hypertension and diabetes
4. Exclusion criteria for volunteers undergoing both contrast and non-contrast

   MRI scans:
   * Pregnant women:

     1. Women of childbearing potential will be required to have a screening urine pregnancy test
5. Exclusion criteria for

   * Pregnant woman for whom 15 additional minutes lying flat in the MR scanner would represent a risk (i.e. severe claustrophobia, congestive heart failure)
   * Pregnant minor under the age of 18
   * Less than 13 weeks gestation
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.


Eligibility Criteria:
Inclusion Criteria:

* Competent and willing to voluntarily provide informed consent
* 18 years of age or older
* In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia

Exclusion Criteria:

* No allergies to the medications and/or the active ingredients of any of the study medications
* No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
* No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.

51 subjects were selected and separated into two groups: those new to the treatment (Group 1)and those who had been in treatment for more than 1 year (Group 2). There were 32 participants in group 1 and 19 in group 2. mean age for Group 1 was 41.7 and Group 2 was 50.5. The age range for Group 1 was 21 to 66 and in Group 2 34 to 73.

Group 1 subjects were fitted with a Luco hybrid OSA appliance (LHOA). They were followed over a 14 day period with adjustments made to the device as required. The second study \[milestone\] was completed at that time.

Group 2 subjects, who had previously been in treatment with the device for and mean of 4.1 years, had an initial study with the device and a second study following 48 hours without the device.

Both groups were studied again at 60 days and results compared.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age (adult)
* capable of giving informed consent
* met the AASM criteria for sleep bruxism
* had sound dentition
* did not have active obstructive sleep apnea(OSA)/upper airway resistance syndrome (UARS)

Exclusion Criteria:

* younger than 18
* incapable of informed consent
* did not meet the AASM criteria for sleep bruxism
* discovered OSA or UARS in the initial study
* did not have sound dentition (active caries, periodontal disease, inadequate number of teeth
* had obstructive sleep apnea/UARS
* did not complete the study
* completed the study but did not complete all aspects of the study
The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic

The goal of this clinical trial is to test whether lycopene (an antioxidant found in cooked tomatoes) will improve the number of swimming sperm in the ejaculates of men with low total motile sperm count.

Participants will take either lycopene capsules or identical capsules containing no lycopene for 12 weeks. We will analyse the quality of their semen before and after taking the capsules, and compare the results.

Hypothesis: Supplementation with lycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).

Impaired testicular function contributes to around 50% of heterosexual infertility and is often characterized by a low total motile sperm count. Evidence suggests that one cause of low total motile sperm count is oxidative stress within the ejaculate, where harmful oxygen species damage the sperm. Antioxidants to combat oxidative stress within the ejaculate have been proposed as a method of increasing the total motile sperm count. Lycopene is a powerful antioxidant found abundantly in cooked tomatoes and has been shown to improve testicular function in a healthy population. This double blinded randomised controlled trial aims to investigate whether lycopene can improve testicular output in participants with a low motile sperm count. Semen analysis will be carried out before and after the intervention. The intervention is a commercially available lycopene capsule or an identical placebo.

Hypothesis: Supplementation with lactolycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).

Eligibility Criteria:
Inclusion Criteria:

1. Males aged 18 - 50 years of age
2. Attending the Fertility Clinic at the Jessop Wing, (Sheffield Teaching Hospitals).
3. Found to have poor testicular function as evidenced by a low motile sperm count (\<20 million motile sperm per ejaculate).
4. Willing to comply with the study procedures and provide informed consent.

Exclusion Criteria:

1. Participants who report allergy to tomatoes, whey, soy.
2. Men with previous testicular surgery or a current or previous diagnosis of cancer.
3. Men found to have normal sperm parameters.
4. Known infection with hepatitis or HIV.
5. Men with azoospermia
A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.

This randomized controlled confirmatory study will enroll 216 participants, where half will be randomly assigned to the digital therapeutics (S/W medical device), MORA Cure (n = 108), and half will be assigned to treatment as usual (TAU) (n = 108), to examine safety and effectiveness in individuals with patellofemoral pain syndrome. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The application provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with patellofemoral pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer
2. Patients with peripatellar or posterior patellar pain provoked by squatting
3. Patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, running, going up or down stairs, kneeling, compression of the patella, palpation of the patellar facets
4. Patients who signed a written informed consent form

Exclusion Criteria:

1. Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale
2. Patients diagnosed with a fracture or dislocation around the knee within the last 3 months
3. Patients who had knee surgery within the last 3 months
4. Patients diagnosed with patellar tendinitis based on imaging within 3 months
5. Patients taking narcotic pain medications for pain control
6. Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening
7. Patients who are pregnant
8. Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening
9. Patients deemed unsuitable for this study by the investigator
LEAP2 Kinetics in Healthy Individuals

The study aims to investigate the kinetics of the naturally occurring peptide liver-enriched antimicrobial peptide 2 (LEAP-2) in healthy volunteers. The overall objective is to investigate the physiological importance of LEAP-2 in healthy subjects.

In a recent study, the molecular phenotype of enteroendocrine cells in the small intestine before and after Roux-en-Y Gastric Bypass (RYGB) surgery in obese individuals was examined. Enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for differentially expressed genes by Illumina High Throughput RNA-sequencing. It was discovered that the gene encoding liver-enriched antimicrobial peptide 2 (LEAP2), a naturally occurring peptide in humans, was significantly upregulated compared to baseline expression. Interestingly, LEAP2 was recently shown to antagonize ghrelin function in response to feeding in mice. Moreover, the mature murine LEAP2 peptide is identical in mice and humans. Thus, LEAP2 has been identified as an endogenous peptide that may be able to alter feeding behaviour and maintenance of glucose levels during calorie restriction.

This study aims to investigate the kinetics of exogenous LEAP2 in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men
* Age between 18 and 25 years
* Body mass index between 20-35 kg/m2
* Informed consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary and/or gastrointestinal disorder(s)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Allergy or intolerance to ingredients included in the standardised meals
* First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) \>48 mmol/mol
* Regular tobacco smoking or use of other nicotine-containing products
* Any ongoing medication that the investigator evaluates would interfere with trial participation.
* Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis.

The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology, non-invasive, reliable and affordable by the patient.

The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis.

40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals.

Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected to have a sleep apnea syndrome (Berlin score≥2)
* Able to use a smartphone application
* Be legally able to give consent
* Person affiliated to social security

Exclusion Criteria:

* Patients already treated for SAS
* Patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen.
* Patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the New York Heart Association criteria for class II or III diseases
* Patients treated with myorelaxant medicines
* Patients with a long beard disabling the setting of the mandibular sensor
* Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.
* Person in exclusion period for another study or participating in a medical study testing drugs.
* Subjects not being cooperative or respecting the study instructions, according the investigator.
Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA) and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.

Seventy patients who undergo STSG procedure in Kaohsiung Veterans General Hospital will be recruited. Two donor sites of equal lengths and widths on the same thigh, which are at least 2 cm apart will be covered randomly with AA and BCT each. Wound healing rate and infection rate will be assessed at 7 and 14 days after surgery. Degrees of pain and itchiness will be assessed daily with Visual Analogue Scale for the first 7 post-operative days. Scar appearance will be assessed with Vancouver Scar Scale 1, 3 and 6 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs

Exclusion Criteria:

* systemic steroid
* old scar on thigh
* systemic infection
* anticipated use of antibiotics for more than 24 hours after operation
* pregnancy
* previous chemotherapy within 3 months before operation
* anticipated chemotherapy within 3 months after operation
* not over 20 years old
* non-communicable
* burn area more than 20% total body surface area
* systemic auto-immune disease
* liver cirrhosis
* allergy to carbon fiber or alginate
* anticipated MRI study
* dry wound
Safety, Efficacy of BNT162b2 mRNA Vaccine in CLL

On behalf of the Israel CLL study group the investigators will evaluate the efficacy and safety of BNT162b2 mRNA Covid-19 Vaccine in patients with chronic lymphocytic leukemia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL was according to the IWCLL criteria
* All patients received two 30-μg doses of BNT162b2, administered intramuscularly 3 weeks apart. (Pfizer).

Exclusion Criteria:

* previous covid19 virus infection