cyrilzakka/clinical-trials huggingface dataset:
Exercise and Asthma in Obese Adults

This pilot study will use an unmasked, parallel group, randomized design. Thirty adult overweight or obese subjects with mild-moderate persistent asthma will be randomly assigned to one of two groups: 12-weeks of home-based moderate intensity aerobic exercise versus no intervention. The study will include 2 clinic visits and 12 telephone calls. Exercise testing to assess physical fitness levels will occur during visits 1 and 2. Blood sampling for biomarkers, inflammatory markers, and other assessments will be done.

The primary aim of this pilot study is to recruit and retain obese adults with mild-moderate persistent asthma for a study protocol that includes exercise at a moderate intensity level in a home-based setting. The investigators primary hypothesis is that compared to no intervention, 12-weeks of moderate intensity aerobic exercise will attenuate serum levels of adipokines (leptin, adiponectin), and other pro-inflammatory markers. The investigators will also analyze the effect of the intervention on fitness levels, pulmonary function, asthma symptoms, asthma control, and asthma-related quality of life.

Given that this is a proof of concept/feasibility study, there is no primary outcome measure. The following measures will be assessed:

* Obesity related biomarkers and other markers of inflammatory responses:
* Asthma symptoms and asthma control measures:
* Lung function
* Fitness levels and physical activity levels:

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed asthma
* Currently prescribed a daily controller asthma medication as evidence of mild-moderate persistent asthma
* Body Mass Index BMI ≥ 30-45 kg/m2

Exclusion Criteria:

* Individuals who undergo aerobic exercise regularly (3 or more times per week for more than 20 minutes) 6 months prior to the study
* Participants with very severe obesity (WHO obese class III) - BMI≥ 45 kg/m2
* Individuals with other clinically significant major illnesses, such as congenital heart disease, juvenile arthritis, inflammatory bowel disease, cystic fibrosis, or other conditions that would limit participation in the exercise protocol or interfere with study measurements will not be eligible.
* Uncontrolled hypertension (resting systolic blood pressure \> 150mmHg, and/or diastolic blood pressure \>90 mmHg despite anti-hypertension medications.
* Current use of beta blockers
* Currently pregnant, pregnant during the previous six months, or planning to become pregnant in the next three months as obtained by self-report.
* Participants who have experienced a clinically significant exacerbation within the past 6 weeks will be excluded. This includes an unscheduled physician visit, emergency room visit, or hospitalization related or use of systemic corticosteroids for asthma.
* Unable or unwilling to provide consent
* Unable or unwilling to perform the exercise protocol and provide study measurements,
* Inability to perform baseline measurements
* Intend to move out of the area within 3 months from the start of the study
* Inability to be contacted by telephone
Alglucosidase Alfa Pompe Safety Sub-Registry

To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated reactions following treatment with alglucosidase alfa.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be enrolled in the Pompe Registry;
* Provide a signed patient information and authorization form;
* Have a confirmed diagnosis of Pompe disease (confirmation of diagnosis is defined as documented GAA enzyme deficiency from any tissue source and/or documentation of 2 GAA gene mutations);
* Be naïve to and plan to be treated with alglucosidase alfa at or prior to enrollment, or are being treated with alglucosidase alfa.

Exclusion Criteria:

* Patients will be excluded if they have received an investigational drug (excluding alglucosidase alfa) within 30 days prior to signing a Safety Sub-Registry Patient Information and Authorization form, or if they are taking or plan to take any investigational product while enrolled in the Safety Sub-Registry.
Add-on to Micamlo BP Trial

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.


Eligibility Criteria:
Inclusion criteria:

* Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be \>=90 and \<=114 mmHg and mean seated systolic blood pressure (SBP) must be =\<200 mmHg
* Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
* Age 20 years or older

Exclusion criteria:

* Patients with known or suspected secondary hypertension
* Patients with clinically relevant cardiac arrhythmia
* Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
* Patients with recent cardiovascular events
* Patients with recent stroke events
* Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
* Patients with hepatic and/or renal dysfunction
* Pre-menopausal women who are nursing or pregnant
Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.

The aim of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers. The study will include a comparison between placebo and RUTI® vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Sign the Informed Consent before initiating the selection procedures.
2. Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2.
3. People ≥ 18 years.
4. Willingness to meet the requirements of the protocol.
5. Negative Rapid Serological Test of SARS-CoV-2
6. The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.

Exclusion Criteria:

1. Previous SARS-CoV-2 infection
2. Pregnancy. Pregnancy test will be performed in case of doubt.
3. Breastfeeding.
4. Suspected of active viral or bacterial infection.
5. Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
6. Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
7. Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study.
8. Severely immunocompromised people. This exclusion category includes:

   1. Subjects with human immunodeficiency virus (HIV-1).
   2. Neutropenic subjects with less than 500 neutrophils / mm3.
   3. Subjects with solid organ transplantation.
   4. Subjects with bone marrow transplantation.
   5. Subjects undergoing chemotherapy.
   6. Subjects with primary immunodeficiency.
   7. Severe lymphopenia with less than 400 lymphocytes / mm3.
   8. Treatment with any anti-cytokine therapy.
   9. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months.
9. Malignancy, or active solid or non-solid lymphoma from the previous two years.
10. BCG vaccination in the last 1year.
11. Soy allergy.

12 Chloroquine or hydroxychloroquine administration in the last two weeks.

13. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.

14 Retirement, transfer, long-term leave (\> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study.

15. Employee at the health center \<22 hours per week.

16. Do not have a smartphone.

17. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol.

18. Any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.
The Clinical Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia

The first purpose of this study is to find out the clinical benefit and risk of oral aspirin for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in patients in the real world.

The second purpose of this study is to get the prediction model of aneurysm's rupture in patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia , and find out who is suitable for oral aspirin.

The investigators try to collect the information of the patients have unruptured intracranial aneurysm combined with cerebral ischemia when oral aspirin.The characteristics of this study are large sample, multi center and prospective.In the real world, more and more patients are checked out unruptured intracranial aneurysm combined with cerebral ischemia.The investigators can collect the information such as how they use aspirin (dose, frequency, duration of treatment), demographic information, past history, daily life habits, morphological characteristics of the aneurysm, how they use other antithrombotic drugs.The investigators will record whether the aneurysm ruptured and have hemorrhage, ischemic stroke, death, changes in the morphology of aneurysm, MRI permeability image index changes. Finally the investigators will get the clinical benefits and risks of using aspirin and build the prediction model of rupture and hemorrhage for aneurysm, find out who is suitable for oral aspirin.

Eligibility Criteria:
Inclusion Criteria:

1. has the diagnosis of unruptured intracranial aneurysm (using the CTA/DSA,smaller than 7mm)
2. has the history of TIA or any other diseases of cerebral ischemia
3. older than 18 years old
4. sign the informed consent

Exclusion Criteria:

1. has the history of intracranial aneurysm rupture hemorrhage or has more than one aneurysm untreated
2. has a family history of intracranial aneurysm
3. has AVM，MMD, intracranial tumor, hydrocephalus or intracranial hemorrhage
4. refuse to sign the informed consent
5. allergic to contrast medium
Central Neuromodulation of Pain Through Music in Healthy Subjects

The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

Pain is a multidimensional, complex and universal phenomenon that would be faced by almost one in two European adults. To meet the needs in terms of public health, contemporary medicine is gradually reintegrating the use of complementary therapeutic methods. Music therapy is a non-medical intervention that is particularly suited to pain problems. The therapeutic use of music is an economical, practical and safe method. Many clinical studies show that this activity promotes a significant decrease in pain. The ability of passive listening to music to reduce the perception of pain has been called "music-induced analgesia". The neuro-psycho-physiological mechanisms that underlie this phenomenon remain poorly understood. One hypothesis, still discussed, proposes that listening to music would stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from the brainstem. In individuals undergoing nociceptive tonic stimulation, the specific neuronal activation induced by listening to music demonstrates the involvement of inhibitory descending pathways. A measurement of pain control mechanisms would account for the impact of music on central awareness.

The purpose of this research is therefore to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18 to 65
* Subjects informed of the constraints of the study and having given their written consent.
* Subjects benefiting from a social security scheme.

Exclusion Criteria:

* Subjects under 18 and over 65
* Subjects who have previously participated in a pain study involving the induced pain test.
* Subjects with serious psychiatric disorders.
* Subjects with a diagnosis of acute or chronic pain.
* Subjects who have been taking antalgic substances for less than a week.
* Subjects with progressive disease not stabilized by medical treatment.
* Women in menstruation.
* Pregnant women.
* Subjects with a score greater than 10 for the Depressive Dimension on Hospital Anxiety and Depression Scale (HADS)
* Subjects with an anxiety score "state" higher than anxiety "traits" on the Spielberger condition state / traits anxiety inventory (STAI)
* Subjects with a score of 32 or higher on the Catastrophe Rating Scale (PCS-CF)
* Non-cooperating person.
* Person under legal protection
* Subjects not benefiting from a social security scheme
* Refusal of participation
Prevalence of Periodontal Diseases in IBD

Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. Recently, periodontal diseases have been correlated with inflammatory bowel diseases (IBD). IBD include two types, Crohn's disease and Ulcerative Colitis. It could be a significant risk factor for the pathogenesis of periodontal disease. These diseases present common features : a high prevalence worldwide, multifactorial pathogenies with common mechanisms. To date, no study has linked activity of IBD and periodontal diseases. The authors hypotheses that the prevalence of periodontal diseases could be increased in patient presenting an active IBD

The present study explores the prevalence of periodontal diseases regarding to the activity status of IBD (active versus non-active).

Diseases activity will be assessed by HBI (Crohn's disease) or partial Mayo score (Ulcerative Colitis) associated with fecal calprotectin and/or CRP and/or inflammatory/ulcerative lesions.

Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases (Chicago 2017) and based on the decision-making algorithms by Tonetti and Sanz. A periodontal screening, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations relative to IBD, treatment need (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated. These data will be collected by a periodontist.

The principal hypothesis of this study is that the prevalence of periodontal diseases could be increased in patient presenting an active IBD.

The primary objective is to evaluate if patients presenting active IBD present more stage III and IV periodontal diseases than non-active IBD ones.

The second objectives are :

* to compare periodontal diseases, gingivitis and oral mucosa dermatological manifestations rates according to the diseases activity, the IBD type and the treatment used to treat IBD,
* to compare oral treatment need according to the activity and the type of IBD,
* to compare quality of life related to oral health according to the activity and the type of IBD

Eligibility Criteria:
Inclusion Criteria:

Patients

* consulting Gastroenterology departments in the university hospital of Reims or Amiens-Picardie for the management of Crohn's disease or Ulcerative colitis
* signed informed consent form
* affiliated to the French Social Security system

Exclusion Criteria:

Patients presenting:

* a medical history likely to compromise protocol (psychiatric disorders, other inflammatory diseases, antibiotics, NSAIDs within the last 3 months)
* Diabetes
* Inflammatory rheumatism
* Cancer or radiotherapy up to5 years before inclusion
* X-ray therapy in the area of interest
* Pregnancy or Breastfeeding
* Eating disorders
* Patients under legal protection, trusteeship or guardianship
Optimum Platelet Inhibition After Coronary Bypass Surgery

To investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent.

Exclusion Criteria:

Preoperative exclusion criteria:

* patients who are have not stopped aspirin 7 days prior to surgery
* patients on concomitant NSAIDS
* patients with a previous history platelet disorders, splenectomy or haematological disorders
* patients with aspirin induced asthma
* patients with any contraindications to aspirin (GI bleed)
* patients who are on any medication that may result in a serious drug interaction with aspirin (warfarin)
* Women of childbearing potential
* Patients of less than 18 years
* If informed consent cannot be obtained
* If for any reason the consultant surgeon or anaesthetist deems it to be appropriate

Operative exclusion criteria:

• Concomitant procedures

Postoperative exclusion criteria:

* patients who receive platelet transfusion
* patients who receive NSAIDS
* requirement for intra aortic balloon pump support
* failure of extubation within 24 hours
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.


Eligibility Criteria:
Inclusion Criteria:

1. At least 36 weeks gestation, and either one of the following criteria (i.-iii.) i. Apgar score ≤5 at 10 minutes ii. Continued resuscitation for at least 10 minutes iii. pH \<7.0 or base deficit ≥16 mmol/L in any blood sample obtained within 60 min of birth
2. Moderate or severe encephalopathy by a Sarnat criteria
3. Undergone therapeutic hypothermia started before six hours of birth, and done for 72 hours continuously
4. Birth weight ≥1,800 g
5. Heart rate ≥100/min, and SpO2 ≥90 %
6. Able to provide voluntary written consent after receiving adequate information about the study (consent will be obtained from an acceptable representative)

Exclusion Criteria:

1. Suspected or confirmed severe congenital abnormalities or chromosomal anomaly
2. Planned to undergo surgery or radiation therapy
3. Scheduled to take systemic corticosteroids treatment for over five days
4. Blood glucose ≥ 200 mg/dL
5. Participation in another clinical study (not exclude patients in observational studies)
6. Suspected or confirmed active and severe infection
7. Positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody or syphilis serum reaction
8. History of severe hypersensitivity or anaphylactic reaction
9. Severe complications
Transcranial Magnetic Stimulation in Treatment of Attention Deficit/Hyperactivity Disorders

* ADHD is one of the most common psychiatric disorders.
* While most of the attention is directed towards youth, 60% continue to suffer symptoms into adult life.
* Current treatment is effective, but 30% suffer side effects that lowers QOL, and 20% are non-responders.
* Known mechanism of pathophysiology includes hypoactive dopaminergic system, especially at right PFC.
* It is this study hypothesis that by stimulating the right PFC by TMS, it will be possible to alleviate ADHD symptoms.
* A 10 sessions of treatment will by applied on a randomly allocated group of patients, diagnosed with ADHD, in a 2:1 ratio: The first group will receive an actual TMS treatment, and the second group will receive a sham treatment.
* Improvement of objective and subjective ADHD scale will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Established diagnosis of ADHD
* No C/I for TMS
* Has signed an informed consent form

Exclusion Criteria:

* Major Psychiatric disorders (Psychotic or Affective)
* Active use of drugs (4 weeks prior to participation)
* Neurologic disorder such as Epilepsy.
* No use of stimulants during the previous 7 days
Cannabis Use and Relapse After One Week of Contingency Management Therapy

The purpose of this study is to examine the effects of a seven-day combined contingency management (CM) with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse in the following 90-day period in individuals with moderate to severe Cannabis Use Disorder (DSM-5).

The primary aim of this study is to examine cannabis use and rates of abstinence and relapse in individuals with moderate to severe Cannabis Use Disorder (CUD) after intensive 7-day contingency management (CM) procedure to reinforce abstinence from cannabis use. In addition, this study will evaluate the effect of CM with two sessions of brief MI on the severity of cannabis withdrawal signs during the first 7-days of CM treatment and then during the following month.

The study will also focus on prospectively monitoring the sustenance of abstinence and time to lapse and relapse to cannabis use over a 90-day period, using ecological momentary assessment (EMA) via a smartphone-based application. An additional aim will be to evaluate changes in symptoms of CUD during the period following the 7-day using the diagnostic criteria of the DSM-5.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) less than 32;
* Good health as verified by screening examination;
* Able to read English and complete study evaluations;
* Able to provide informed written and verbal consent;
* CUD sample must meet DSM-5 criteria for CUD as assessed using SCID-I and have positive cannabis urine toxicology screens on admission to study, with weekly 3 or more days of self-reported cannabis use.

Exclusion Criteria:

* Meet current DSM-5 criteria for dependence on another psychoactive substance or alcohol, excluding nicotine and mild Alcohol Use Disorder
* Current use of opiates or history of opiate abuse/dependence;
* Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other antihypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, SSRI's, naltrexone, antabuse;
* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
* Significant underlying medical conditions such as a history of seizure disorder, cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude subjects from fully cooperating or be of potential harm during the study; a known history of Hepatitis B, C, or HIV infection;
* Any psychotic disorder or current Axis I psychiatric symptoms (excluding anxiety disorders) requiring specific attention, including need for psychiatric medications
* Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy urine test during initial intake appointment; and
* Traumatic brain injury or extended loss of consciousness.