cyrilzakka/clinical-trials huggingface dataset:
Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss

The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged 18 to 49 years, in general good health
* Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area

Exclusion Criteria:

* Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1
Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.

To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
* Must have been born in Japan, and both their biological parents and grandparents must have been of Japanese origin
* Aged 18 to 55 years old, inclusive, at the time of informed consent, and must have a body mass index between 18 and 30 kilogram per square meter (kg/m2), and a body weight \>45 kg
* All women of childbearing potential and all men must practice highly effective contraception during the study and for 16 weeks after their dose of study treatment

Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
* History or positive test result for human immunodeficiency virus. Current active hepatitis C virus infection (defined as hepatitis C virus RNA above the limit of detection). Positive test result for hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody). Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
* Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 5 half-lives prior to Day -1
* History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug or alcohol test at Screening or Day -1, an unwillingness to refrain from illicit or recreational drugs, or an unwillingness to abide by the alcohol restrictions

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Hypoalgesic Effect of Median Nerve Neural Mobilization Compared to a Controlled Group

The purpose of these study is to compare the effectivity of the Median Nerve Neural Mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.

Median Nerve Neural Mobilization (MNNM) is a non invasive physical therapy technique that achieves pain relief through mechanical stimulation of the Median Nerve and the brachial plexus. It is believed that the hypoalgesic effect offered by the neural tissue mobilization procedure is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical and sensitive properties of the involved neural tissue. The neural tissue mobilization procedure is associated to an increase in nerve mobility, edema, inflammation and intraneural pressure reduction without any known side effects when applied properly which is an important contrast to the wide variety of side effects caused by commonly used drug therapy to treat cervicobrachial pain.

Despite the crescent interest among the scientific community in evidence based options to treat pain there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the (MNNM) and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on Median Nerve Neural Mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cervicobrachial pain confirmed by magnetic resonance imaging
* Presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment.
* Positive results in all of the following tests: Spurling, Distraction, and Upper Limb

Exclusion Criteria:

* Contraindication in the use of nonsteroidal anti-inflammatory drugs (NSAIDs)
* The use of any type of treatment, therapy, procedure or drug to relieve pain
* Patients who are under anticonvulsant, antidepressant or psychotropic medication
* Vertebral instability
* Vertebral osteoporosis
* Vertebral or spine infection.
* Neurologic diseases of genetic, infectious or neoplastic origin
* Cervical stenosis myelopathy
* Pregnancy
* Kinesiophobia
* Endocrine disorders and menopause
* History of spine surgery
* Intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease.
Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis

Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.

Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.

Eligibility Criteria:
Inclusion Criteria:

• Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Systemic diseases.
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane

The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.

The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Informed consent signed and dated by study patient and investigator / authorized physician
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.).
* Ongoing participation in an interventional clinical study during the preceding 30 days
* Previous participation in this study
* Pregnancy (pregnancy test will be conducted with female patients aged less or aged 55 years) or lactation period
Smoking-induced Dopamine Release: a [11C]-(+)-PHNO PET Study in Humans

This study will evaluate effects of smoking on the dopaminergic system by using PET tomography with new radioligand, \[11C\]-(+)-PHNO. Our primary hypothesis is that smoking a cigarette will produce dopamine release and this release can be measured using PET imaging and the \[11C\]-(+)-PHNO radiotracer. The secondary hypothesis is that this smoking induced dopamine release will be correlated with subjective craving and anxiety ratings.

This will be a within-subjects study in healthy male and female smokers. There will be one within factor condition: Smoking and Non Smoking. Therefore, there will be a repeated measure of PET scans using \[11C\]-(+)-PHNO under two different conditions. Ten subjects (n=5 male and n=5 female) included in the study will come on two different days and will have a Smoking or Non smoking session performed just before the PET study. Subjective assessments will be conducted at each experimental condition.

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females
* Regular smoking of at least 10 cigarettes, excluding ultra-low nicotine cigarettes, per day for at least two years
* Score on the Fagerstrom Test for Nicotine Dependence of 4 or more
* No intention to quit or reduce tobacco use, and no treatment for tobacco dependence currently
* No history of abuse of or dependence on any other drug, defined by DSM-IV criteria

Exclusion Criteria:

* Pregnancy
* Presence of metal objects in the body or implanted electronic devices, that preclude safe MR scanning
* Claustrophobia
* Cardiovascular or cerebrovascular diseases
* Major psychiatric disorders including mood, anxiety or psychotic disorders
* History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor
* Gross structural brain abnormalities as revealed by T1 weighted images
* Current use or use during the previous month of medication that may affect the CNS (e.g. neuroleptics, bupropion)
* Learning disability, amnesia or other conditions that impede memory and attention
Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
* Patients under 1st line treatment against lung adenocarcinoma.

Exclusion Criteria:

* Patients not having the information required by the protocol.
ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will decrease disease activity and improve quality of life in patients with established RA.

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the population, and where many patients in spite of modern pharmacological treatment fail to reach remission. This affects physical as well as mental wellbeing and leads to severely reduced quality of life and reduced work capacity, thus yielding high individual as well as societal costs. To optimize treatment, alternatives such as diet should be evaluated as complement to pharmacological treatment. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will decrease disease activity and costs and improve quality of life in patients with established RA. In total, 60 RA patients with moderate disease activity will be randomized to receive initially either a portfolio diet based on several food items with suggested anti-inflammatory effects or a control diet (western type), during 2 x 10 wks with a 3 months wash-out between diets. Both groups continue with regular pharmacological treatment. Known food biomarkers will be analyzed to measure intervention compliance. Impact on disease activity (measured by DAS28, a composite score which predicts disability and progression of RA) and quality of life is evaluated after each diet regimen. Metabolomics will be used to evaluate the potential to predict responders to dietary treatment. ADIRA will provide evidence whether dietary treatment of RA leads to more patients reaching remission and improved quality of life and work capacity as well as reduce individual and societal costs. Scientific evidence exists for anti-inflammatory effect by single foods on RA, but no study exists where these foods have been combined to obtain maximum effect and thus have the potential to offer a substantial improvement in patient life quality. Such evidence has been asked for by RA patents as well as by treating physicians.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with established RA, disease duration \>2 years, disease activity DAS28 \>= 2.6 and a disease that is clinically stable and under adequate control and medication, will be invited to participate.

Exclusion Criteria:

* Other life threatening diseases, pregnancy, lactation, food intolerance or allergy to food included in the trial, ability to understand information in Swedish
Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis

Aim of the work

Assessment of early outcome of using Roflumilast in patients with bronchiectasis regarding:

* Severity of symptoms
* Frequency of exacerbations
* Change in pulmonary function
* Systemic inflammation

Bronchiectasis is defined by the presence of permanent and abnormal dilation of the bronchi. This usually occurs in the context of chronic airway infection causing inflammation. The main clinical manifestation is a productive cough. Bronchiectasis is currently nearly always diagnosed using high-resolution computed tomography (HRCT) scanning. The main diagnostic features are: 1) internal diameter of a bronchus is wider than its adjacent pulmonary artery; 2) failure of the bronchi to taper; and 3) visualization of bronchi in the outer 1-2 cm of the lung fields.

* From a series of benzamide derivatives, roflumilast (3-cyclo-propylmethoxy-4-difluoromethoxy-N-\[3,5-di-chloropyrid-4-yl\]-benzamide) was identified as a potent and selective PDE4 inhibitor. It inhibits PDE4 activity from human neutrophils. PDE4 inhibitors were demonstrated to inhibit inflammatory cytokine and mediator release from inflammatory cells. In addition, it inhibits neutrophil chemotaxis or migratory activity. Lastly, PDE4 inhibitor promotes apoptosis of these cells .
* Studies have demonstrated the efficacy of roflumilast in patients with both asthma and COPD, where roflumilast improved lung function and reduced exacerbation rates.
* Bronchiectasis is a chronic destructive lung disease, which is characterised by persistent bacterial colonization, bronchial inflammation, reduced mucociliaryclearance, and in some patients progressive tissue damage. There is evidence of an associated influx of neutrophils into the lungs of these patients , resulting in the expectoration of large volumes of purulent sputum containing neutrophils and their products, so In patients with bronchiectasis, there is also neutrophilic inflammation as in COPD.

  * The PDE4 inhibitor, roflumilast, was evaluated in short term clinical trial of non-cystic fibrosis bronchiectasis. It has been shown symptomatic improvement from baseline Park J. found that 16 weeks Roflumilast treatment in patients with non cystic fibrosis bronchiectasis significantly reduce CAT score and improve the symptoms of non-CF bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above, male or female.
* Non / Ex-smokers.
* Confirmed diagnosis of bronchiectasis based on high-resolution computed tomography scan.
* Significant sputum production (≥ 10 ml per day).

Exclusion Criteria:

* Non-stable patients who need ICU admission /mechanical ventilation.
* Active smokers.
* Moderate to severe liver impairment (Child-Pugh B or C) and/or sever renal impairment (c. clearance less than 30ml/min).
* Known psychiatric illness
* Concomitant use of strong cytochrome P450 inducers (e.g. rifampicin)
* Patients who are hypersensitive to roflumilast.
* Pregnant or lactating women
School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents

Background and objective:

There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits.

Methodology:

A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old.

Expected results:

The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.


Eligibility Criteria:
Inclusion Criteria:

* • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Exclusion Criteria:

* No exclusion criteria.
Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate


Eligibility Criteria:
Inclusion Criteria:

* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints.

Exclusion Criteria:

* A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)

The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.

Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.

Assessment of the performance of ANI to detect NRS\>3 and NRS\>=7 by building ROC curves.

Eligibility Criteria:
Inclusion Criteria:

* adult
* surgical or endoscopic procedures performed on general anesthesia

Exclusion Criteria:

* age \<18 yrs or \>75 yrs
* arrythmia
* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* psychiatric diseases
* autonomic nervous system (ANS) disorders
* inability to understand the verbal rating pain scale.
Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

This observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at Stanford Pain Management Center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.

Ketamine is a type of anesthetic drug which has been used off-label to treat chronic pain. The effectiveness of intravenous ketamine and its duration of effect are not well-understood. There is high variability in response to ketamine, and it remains unclear which patient characteristics are associated with favorable outcomes. This observational study will collect a wide range of patient-reported outcomes via digital surveys: once at baseline before treatment, and up to 7 follow-up surveys for up to 12 months following a single ketamine infusion. Survey data will be supplemented by clinical data obtained from electronic medical records.

Eligibility Criteria:
Inclusion Criteria:

* Has been seen at Stanford's Pain Management Center for a doctor's visit at least once.
* Is scheduled to undergo at least 1 ketamine infusion for the treatment of any chronic pain condition.
* Have a valid email address and consents to receiving surveys by email.
* Able to read, understand, and respond to English-language surveys on an electronic device such as a cell phone, tablet, or computer.
* Able to read, understand, and provide written, dated informed consent.

Exclusion Criteria:

* Has their ketamine infusion cancelled, which may occur before or after consenting to this study.