cyrilzakka/clinical-trials huggingface dataset:
Clinical Research Study Efficacy of a Prototype Oral Rinse

Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation


Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers 18-65 years of age
2. Good general health
3. Must sign informed consent form
4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
5. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

Exclusion Criteria:

1. Subjects unable or unwilling to sign the informed consent form.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease
4. History of allergy to iodine
5. History of thyroid disease
6. History of diabetes
7. 2 or more decayed untreated dental sites at screening.
8. Other disease of the hard or soft oral tissues.
9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
10. Use of medications that are currently affect salivary flow.
11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
12. Pregnant or nursing women.
13. Participation in any other clinical study within 1 week prior to enrollment into this study.
14. Use of tobacco products
15. Subjects who must receive dental treatment during the study dates.
16. Current use of Antibiotics for any purpose.
17. Presence of an orthodontic appliance.
18. History of allergy to common dentifrice ingredients
19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
21. Smoker
A Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)

The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).


Eligibility Criteria:
Inclusion Criteria:

* Female at least 18 years of age, and able to provide informed consent
* Females who are post-menopausal defined, as not have menses for at least 12 months without an alternative medical cause and elevated follicle stimulating hormone in the postmenopausal range as measured during screening
* Have active FFA that has been diagnosed on or prior to screening visit.
* Have LPPAI score equal to or greater than 5 at screening.
* Have evidence of eyebrow loss at baseline
* Have evidence of hairline recession at baseline
* Have classic presentation with frontal loss of scalp hair
* Negative screening for tuberculosis (Quantiferon Gold, T-spot) within 3 months prior to screening or at the screening visit.
* Agree not to have a live vaccination during the study the exception is herpes zoster vaccine

Exclusion Criteria:

* Systemic treatments for FFA within 4 weeks of the baseline visit or 5 half lives whichever one is longer. (ex: finasteride, pioglitazone, hydroxychloroquine, or immunosuppressant medications, such as mycophenolate mofetil).
* Dutasteride within the last 6 months
* Have a LPPAI score less than 5 at screening
* Immunocompromised and with risk factors concerning to investigator for study participation
* Previous treatment with an oral JAK inhibitor
* Any condition in the opinion of the investigator which would interfere with the study assessments or procedure
* Subject is pregnant or breast feeding
* Surgical intervention including face lifts and micro-blading on the treatment areas
* Any intervention (facelifts micro blading) that could affect the treatment areas (i.e. scalp and eyebrows)
* Laser or phototherapy intervention on the treatment areas
* Have evidence of active TB or latent TB
Post Marketing Surveillance Study on Emselex After Launch in Germany

- Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with Emselex for Overactive Bladder

Exclusion Criteria:

* Exclusion criteria are the contraindications as specified in the German product information
Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery

Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of NAFLD after weight loss. As other factors such as the microbiome or muscle and fatty tissue also influence the development of obesity and liver diseases, it is planned to examine these parameters before and after bariatric surgery as well.

Tissue biopsies will therefore be taken during the surgery, and blood as well as stool samples will be collected and compared for suitable biomarkers before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI above 40 kg/sqm or
* BMI above 35 kg/sqm and comorbidities related to morbid obesity (e.g. type 2 diabetes, hypertension, coronary heart disease, dyslipoproteinemia, sleep apnea, and others

Exclusion Criteria:

* BMI below 35 kg/sqm
* no informed consent
* patient not suitable for bariatric surgery (severe psychological disorder, pregnancy, drug abuse, active malignant or other consuming disease
Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease

Cognitive impairment is a poorly understood, serious, and emerging complication for adult patients with sickle cell disease. Because there is extensive microvascular damage from oxidative damage in sickle cell disease, the investigators hypothesize that this is also present in the cerebral microvasculature to cause cognitive impairment. The investigators plan to test this by correlating markers of inflammation and oxidative damage with cognitive performance and 7 Tesla brain MRI microvascular findings in these patients, with the long term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle cell disease.

The Neurovascular Determinants of Cognitive Function in Adults with Sickle Cell Disease is a study for adults 18 and older who have been diagnosed with Sickle Cell Disease (SCD). Many adult patients with SCD suffer from cognitive impairment (CI), a serious complication responsible for severe functional limitations, and whose pathogenesis, risk factors, and natural history are unknown. This research project will look at cognitive performance and 7 Tesla brain MRI findings along with markers of inflammation and oxidation to better understand the mechanism and risk factors. The investigators will complete a baseline assessment. SCD participants will be seen for follow-up at 3 and 5 years. Non-SCD participants will be seen for follow-up at 3 years. All assessments are completed at no cost and there is compensation for participation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above
2. Able to provide informed consent

For Non-SCD :

1. Between age 18 and 55
2. Able to provide informed consent
3. Are age, race, and gender matched to a Sickle Cell Disease study subject.

Exclusion Criteria:

1. Age less than 18 years
2. Current pregnancy or lactation
3. Any medical condition that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:

   1. Diabetes mellitus
   2. Coronary artery disease
   3. Peripheral vascular disease
   4. Other causes of cerebral vasculitis such as Systemic Lupus Erythematosus (SLE)
4. Any contraindication to MRI scanning including:

   1. History of claustrophobia
   2. Presence of metallic implants such as cardiac pacemaker or implantable defibrillator, surgical aneurysm clips, or any implanted device (e.g. insulin pump, drug infusion device)
   3. Any known metal fragments embedded in the body (eg: ear implant)
   4. Neural stimulator (e.g. Transcutaneous Electrical Nerve Stimulation Unit)
   5. Metal in the eye (e.g. from machining)
   6. Any metallic foreign body, shrapnel, or bullet
   7. Inability to lie still for 30 minutes or more
5. Inability to provide direct consent
6. In a current medical or pain crisis as diagnosed by attending physician -
Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome

is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 \<0.30.

Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.

Non-invasive respiratory support failure is set as follows:

* FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
* Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
* Persistent acidosis; presence of pH \< 7.20 and PCO2 \> 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
* Severe respiratory distress,
* Pulmonary haemorrhage and cardiopulmonary arrest.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included

Exclusion Criteria:

* Major congenital anomalies
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused
Stem Cell Therapy in Muscular Dystrophy

The purpose of this study was to analyze the effect of autologous bone marrow mononuclear cells in muscular dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* age group of 6 months and above
* muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding
The Lumbar Trident Study

This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic lumbar facet joint pain.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients with lumbar pain
* Patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections

Exclusion Criteria:

- No patient related outcome measures available in hospital's patient charts
Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition


Eligibility Criteria:
Inclusion Criteria:

* Knee joint ROM normal or near normal: flexion 110 ° or reach 0 ° or less
* MR prompt exist cartilage damage, there is no lack of full-thickness cartilage
* Kellgren - Lawrence (K - L) grade II - III grade
* The international association of cartilage repair cartilage damage grading system (ICRS) class I - III
* Informed consent and sign relevant documents
* Follow doctor's instructions and follow up on time

Exclusion Criteria:

* Metabolic arthritis
* Trauma of bone joint
* Inflammatory diseases
* Previous knee surgery history
* History of knee cavity injection in the past 6 months
* Serious cardiovascular diseases, pulmonary diseases or other serious diseases affecting survival, etc
Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis

Compression ultrasound is commonly used in emergency department. Accuracy to rule out deep vein thrombosis is excellent but lower then Ddimer assessment which is actually gold standard. With progress in formation of emergency physicians (EP), quality of material used, the investigators hypothesize that compression ultrasound can rule out deep vein thrombosis in case of non high probability, as standard care and DDimer assay.


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* Patient presenting to the emergency department with clinical suspicion of DVT (i.e. pain and/or lower extremity edema).
* Patient with a non-high probability according to the modified Wells score, i.e. a score of 0 or 1
* Subject with a social health insurance plan
* Subject able to understand the objectives and risks of the research and to give a signed and dated informed consent

Exclusion Criteria:

* Patient with suspected pulmonary embolism
* Patient with a high probability of DVT
* Impossible to perform a whole leg doppler ultrasound within 5 days
* Pregnant or breast-feeding woman, on patient's declaration
* Subject under court protection
* Subject under guardianship or curatorship
3 Year Follow up on ANO5 Patients

The aim of the study is to investigate progression in muscle affection in patients with pathogenic variants in the anoctamin 5 gene to:

1. investigate possible progression of disease over time
2. investigate good and reliable outcome measures

Muscles of patients with pathogenic variants in the anoctamin 5 gene will over time be infiltrated with fat. This is especially visible on MRI and can be seen even before any symptoms appear. MRI is thus used increasingly to investigate muscle affection in neuromuscular disorders. Together with functional measurements it is possible to describe how patients are affected clinically and subclinically. There are still many things that need covering - rate of progression is undertermined and good outcome measures are still needed for future clinical trials.

Muscles of the whole body in patients with neuromuscular disorders will be investigated 3 times through a 3 year follow-up study.

The aim of the study is to investigate progression in muscle affection in patients with pathogenic variants in the anoctamin 5 gene to:

1. investigate possible progression of disease over time
2. investigate good and reliable outcome measures

Eligibility Criteria:
Inclusion Criteria:

* Pathogenic variant in the anoctamin 5 gene
* Age more than 18 years

Exclusion Criteria:

None
Early Rehabilitation of Patients With Posttraumatic Amnesia

The purpose of this study is to investigate if a systematic intervention with early identifying of patients with posttraumatic amnesia using a reality orientation therapy can reduce the period with posttraumatic amnesia in order to get a better outcome for patients with traumatic brain injury

1. A systematic review with the latest investigation and treatment of patients with posttraumatic amnesia
2. Investigate the effect of a systematic nursing programme on the length of posttraumatic amnesia
3. Investigate the effect of a systematic nursing programme after 12 month
4. Describe perspectives for the future within the early rehabilitation of patients with posttraumatic amnesia

Eligibility Criteria:
Inclusion Criteria:

* Patients should be able to speak and understand danish
* Patients with traumatic brain injury
* A verified brain injury at the CT scanning

Exclusion Criteria:

* Patients with medical illness
* Patients with other neurological illness
* Patients with neuroinfections meningitic, encephalitic
* Patients who does not understand and speaks danish
The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests

Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing this procedure. The investigators intend to examine if medical clowns compared with local anesthetic cream can decrease these feelings in children.


Eligibility Criteria:
Inclusion Criteria:

* Any child undergoing allergy prick skin test

Exclusion Criteria:

* Children suffering from coulrophobia (phobia of clowns)
* Children with a known hypersensitivity to EMLA 5% cream
* Children who have undergone a painful medical procedure (surgery, dental procedures, blood drawing) over the past 3 months
* Children who, for medical reasons, must have their skin test performed on an area other than the volar aspect of the arm
Development of a Questionnaire to Assess Patient Knowledge About Non-vitamin K Anticoagulants (NOAC)

Pharmacists are in the best position to counsel and educate patients on anticoagulant agents such as NOACs. This should enable patients to play a more active role in their treatment and ultimately enhance adherence behaviour. However, educational elements should be targeted to knowledge. Thus, the investigators will develop and validate a questionnaire that can assess knowledge about NOACs


Eligibility Criteria:
Inclusion Criteria:

* Intake of a NOACs (Rivaroxaban, Edoxaban, Dabigatran, Apixaban)
* ≥18 years
* Able to give written Informed consent in German

Exclusion Criteria:

* NOACs for orthopaedic indication
* Dementia in medical history
Hydrodissection in Carpal Tunnel Syndrome

Compare the efficacy on carpal tunnel syndrome (CTS) treatment between hydrodissection with hyaluronic acid (HA) vs 5% dextrose

Compare the efficacy on carpal tunnel syndrome treatment between hydrodissection with hyaluronic acid vs 5% dextrose through ultrasonographic evaluation.; 2) Evaluate the association of median nerve gliding results between using duplex Doppler ultrasound and B mode video with cross-correlation algorithm.

Eligibility Criteria:
Inclusion Criteria:

* 20-80 years old patients with carpal tunnel syndrome

Exclusion Criteria:

* pregnancy, Diabetes, hypothyroidism, uremia, rheumatoid arthritis, coagulopathy, cervical radiculopathy and patients who has ever received surgery for carpal tunnel syndrome or wrist fracture
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder

The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.2.
* Participants whose incipient age of depression was ≥7 years old.
* Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.

Exclusion Criteria:

* Have remarkable response to psycho-education (defined as \>30% decrease in the total score of CDRS-R between screening and baseline).
* Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:

  * Neurodevelopmental disorders
  * Schizophrenia spectrum and other psychotic disorders
  * Bipolar and related disorders
  * Trauma and stressor-related disorders
  * Disruptive · Impulse Control · and Conduct disorders
* Have a current diagnosis (DSM-5) of the following as judged by the investigator:

  * Obsessive-compulsive and related disorders
  * Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
  * Sleep-wake disorders
  * Neurocognitive disorders
  * Disruptive mood dysregulation disorder
* Have personality disorders, in the judgement of the investigator.
Efficacy of Structured Insulin Order

The purpose of this study is to determine whether an electronic order template for basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients with poorly controlled type 2 diabetes.

The study randomly assigned internal medicine residents to use an electronic insulin order template plus basal-bolus ordering education versus education only. For all patients with uncontrolled type 2 diabetes treated by these physicians, mean blood glucose, rate of hypoglycemia, and rate of sliding scale insulin use were measured.

Eligibility Criteria:
Inclusion Criteria:

* Blood glucose less than 60 mg/dl or greater than 180 mg/dl during hospital stay

Exclusion Criteria:

* Diagnosis of Type 1 Diabetes
Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial Performance?

The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance.


Eligibility Criteria:
Exclusion criteria:

* Any diagnosed metabolic health condition
* Pregnant
* Non-habitual caffeine intake
* Smoker
* No endurance training
* Diagnosed Cardiovascular disease
* Recent history of musculoskeletal injury
* Anti-depressant and anti-anxiety medication

Inclusion criteria

* Age 18-40
* Healthy
* Highly trained endurance athletes (V̇O2max: males \>55 and females \>50 mL⋅kg bm-1⋅min-1)
* Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.