cyrilzakka/clinical-trials huggingface dataset:
Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy

We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort

Background: Dietary exposures in fetal life may have long lasting impact on the individual's susceptibility for several non-communicable diseases. Although offspring's own dietary habits become increasingly independent from parental influence other external factors are likely to exist. Further insights are needed to interpret and separate potential influence from exposures in pregnancy from later dietary habits on later disease risk.

Objectives: We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC).

Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary intake assessed at age \~14 years with a 150-item food frequency questionnaire (FFQ) and dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the Danish National Birth Cohort

Exclusion Criteria:

* If mother did not complete a food frequency questionnaire during pregnancy
Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is one of the most common autoimmune inflammatory arthritis affecting 0.5 to 1% population worldwide characterized by synovitis, increased inflammatory markers and progressive bone and cartilage erosion. RA is associated with an increased cardiovascular morbidity and mortality compared with the general population.

Although inflammation has been shown to contribute substantially to the development of cardiovascular diseases (CVDs) in patients with RA, there is also a high prevalence of traditional CVD-risk factors among these patients.

The elevated risk has been shown to be attributable to combination of both traditional risk factors hypertension, smoking, dyslipidemia and obesity and RA-specific factors rheumatoid factor (RF) positivity, rheumatoid factor (RF) positivity and Disease Activity Score including 28 joints (DAS28).

Periodontitis, a chronic inflammatory disease characterized by loss of the periodontal ligament and alveolar bone, is a major cause of tooth loss.

Periodontal diseases are highly prevalent and can affect up to 90% of the world population with varying degree of disease severity. The prevalence of periodontitis is higher in RA population compared to the healthy individuals.

Studies have reported increased periodontal tissue breakdown in RA patients, certain clinical and pathological similarities exist between both diseases. Pathogenic processes in RA, which is characterized by synovial inflammation and progressive destruction of cartilage and bone, are similar to those in periodontitis.

Periodontitis also has been linked to other diseases known to be associated (higher) with RA as diabetes, CVD, metabolic syndrome, some types of cancer.

Periodontitis is one of the major modifiable risk factor of CVD. Both periodontitis and CVD share common risk factors as smoking, diabetes mellitus, age, socioeconomic status, stress and obesity, which could result in confounding any association between them.

Studies revealed that periodontal treatment improves endothelial function and there was a longitudinal study evaluating the impact of periodontal treatment on c-IMT in people with mild/moderate periodontitis. 6 and 12 months following periodontal treatment, a statistically significant reduction in c-IMT compared to baseline measurements was reported. These associations emphasize the importance of oral health as a common under-recognized factor increasing CV risk.

Eligibility Criteria:
Inclusion Criteria:

* The study participants' will be diagnosed according to 2010 ACR/ EULAR classification criteria of rheumatoid arthritis

Exclusion Criteria:

* Participants with history of CVD event (myocardial infarction, coronary artery disease/reperfusion therapy, stroke, transient ischemic attack) in past or any patient experiencing cardiovascular revascularization surgery or the onset of cerebrovascular disorder within past 6 months or those with serious liver disease or renal disease will be excluded, as well.

Patients with overlap diseases will be excluded
A Study in Head and Neck Cancer

This study will begin with a 30 participant lead-in part: these 30 participants will receive cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs \[cisplatin or carboplatin plus 5-fluorouracil (5-FU)\] administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed.

In the second part of this study, 200 participants will be randomized in 2 arms:

* 100 participants will receive commercial cetuximab manufactured by ImClone (Group A)
* 100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B).

All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer that was confirmed by tissue biopsy or cytology
* Disease not suitable for local therapy
* Measurable or evaluable disease
* Karnofsky performance status (KPS) score of at least 70
* Organs are functioning well (bone marrow reserve, liver and kidney)
* Life expectancy of at least 12 weeks
* Signed informed consent document

Exclusion Criteria:

* Receiving another investigational medication within the last 30 days
* Prior chemotherapy, except if given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
* Nasopharyngeal carcinoma
* Previous treatment with monoclonal antibody therapy or other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy except for prior cetuximab treatment given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
* Uncontrolled high blood pressure
* Heart disease or had a heart attack within the last year
* Currently have an infection that requires for you to take an IV antibiotic
* Currently receiving other therapies for your cancer, such as chemotherapy, radiation therapy, immunotherapy, and hormonal therapy
* Medical or psychological condition that would not permit the participant to complete the study or sign informed consent
* Known drug abuse (with the exception of alcohol abuse)
* Known allergic reaction against any of the components of the study treatment
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Have had another type of cancer within the last 2 years
* You are currently pregnant or breastfeeding
* You are considering becoming pregnant or fathering a child
Symbicort Turbuhaler 30/60 Clinical Experience Investigation

The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Symbicort for the first time due to bronchial asthma

Exclusion Criteria:

-
TyVECO: Surveillance Protocol

In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. Peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. Biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. Hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

At health center:

1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR
2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation

At Hospital:

1. Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) OR
2. Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares

Exclusion Criteria:

* Individuals who do not provide informed consent
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:

* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
* Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
* Tabulation of the number and types of adverse events during ViaNOx-H treatment.
* Comparisons of the response of different organisms to ViaNOx-H treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have a chronic (\> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
* Are 18 years of age or older.

Exclusion Criteria:

* Have had a change in their topical treatment during the last 4 weeks
* Have evidence of Clinical Infection
* Have a transcutaneous oxygen tension \<30mmHg
* Have evidence of the ulcer or infection extending to the underlying muscle or bone.
* Are pregnant.
* Are less than 18 years of age.
BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects

The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

BIIB033 is an investigational product being developed to promote remyelination in subjects with multiple sclerosis (MS). This healthy volunteer study will evaluate safety and tolerability of a single dose of BIIB033.

Eligibility Criteria:
Inclusion Criteria:

* Must be in good health
* BMI of 18-30kg/m2
* Contraception required for at least 6 months after study drug administration

Exclusion Criteria:

* History of clinically significant disease or lab values
* Females of childbearing potentials
* Contraindication to brain MRI and/or lumbar puncture
* Treatment with any prescription medication within the 28 days prior to study entry
* Treatment with any over-the-counter products, including herbal and/or alternative health preparations and procedures within the 14 days prior to study entry
* Regular use of any tobacco product within 3 months prior to study entry
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children

MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.

MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

Each participant must meet all of the following criteria to be enrolled in this trial:

* Is between the ages of 3 and 12 years inclusive at the time of randomisation
* Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

* Has a BMI over the 97th centile for age and gender
* Has a history of tonsillectomy and/or adenoidectomy
* Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
* Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
* Has a history of nasal surgery or trauma which has not fully healed
* Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
* Is assessed to have stertor (snoring) while awake at rest
* Has a known hypersensitivity to the study drug or its formulation
* Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
* Daily use of antihistamine or decongestant nasal sprays
* Is known to require systemic steroids prior to the completion of the study treatment phase
* Has had treatment with any other investigational drug within 6 months prior to randomisation
* Is unable to provide consent without the aid of an interpreter.
* In the opinion of the Investigator may be unable to follow the protocol
Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH

The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study.


Eligibility Criteria:
Inclusion Criteria:

1. ICHD-3 criteria for chronic cluster headache
2. Documented history of CCH since at least 2 years
3. Minimum mean attack frequency of 4 attacks per week
4. Age range: 18-70 years
5. Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.
6. No preventive CH treatment or stable preventive CH medication for ≥ 2 weeks before enrolment. Subject agrees not to change existing treatment during the whole duration of the trial.
7. Subject written informed consent provided before enrolment
8. Subject willing and capable of subjective evaluation and to fill in an electronic CH diary, to understand questionnaires, and to read, understand and sign the written informed consent form.
9. Subject willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

1. Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
2. History of epilepsy, current treatment of epilepsy
3. Documented history of cerebrovascular accident (CVA)
4. Subjects suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
5. Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
6. Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and/or a drug delivery pump, etc.
7. Cranial botulinum toxin injections in the past 3 months before enrolment. Administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide transmission, suboccipital infiltrations with steroids and/or local anaesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO 3.
8. Medication overuse headache (ICHD 3 8.2)
9. Inability to fill out an electronic diary.
10. Previous surgery or trauma involving the cervical spine or the occipital bone
11. Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
12. Concurrent participation in another clinical study
13. Planned pregnancy, pregnancy, or breastfeeding.
Cryotherapy and Joint Biomechanics During Running

The purpose of this study is to determine the immediate effects of cryotherapy on the lower extremity biomechanics during running.

Cryotherapy or cold therapy has widely been used as a treatment modality in both acute and chronic injuries. It is believe that the application of cryotherapy can help to decrease pain, muscle soreness, soft tissue swelling, and cause vasoconstriction of blood vessels reducing heat loss. The nerve conduction velocity and muscle-spindle firing rate also decreases with cryotherapy, which results in changes in proprioception acuity. Cryotherapy has also been used prior to exercise (pre-cooling) to improve endurance activities. However, given the possible detrimental effects of cryotherapy on proprioception acuity, the use of this treatment modality prior to exercise could pose an increased risk of musculoskeletal injury. The effects of cryotherapy on lower extremity biomechanics during athletic movements is poorly understood despite the wide use among physiotherapists, athletic therapists and clinicians. Therefore, the purpose of this investigation is to determine the effects of cold water immersion on lower extremity biomechanics during running. The investigators hypothesize that cryotherapy as a form of treatment can increase the load in the lower extremity joint during gait biomechanics.

Eligibility Criteria:
Inclusion Criteria:

* males or females (18 - 40 yrs)
* no injuries of the lower extremity in the past 6 months prior to participation
* recreationally active
* in good health upon entry into the study
* willing to volunteer for the present project.

Exclusion Criteria:

* lower extremity injury within the last 6 months
* circulatory, vestibular or any contradiction to cryotherapy including Raynaud's disease
Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy.

In a sub-group of patients coronary flow reserve will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)

Exclusion Criteria:

* Patients \>18 years old with moderate to high risk for contrast induced nephropathy undergoing percutaneous coronary intervention
* Low risk for contrast induced nephropathy (Mehran Score \<5)
* Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
* Infection
* Pregnancy, Lactation
* Renal failure requiring dialysis
* Hepatic failure
* Allergy to NAC
* History of Asthma
* Chronic nitrate usage
* Malignancy
* Use of corticosteroids
* Leucocytosis,Thrombocytosis,Anemia
* Blood pressure of \>180/100mmHg despite anti-hypertensive therapy
Diabetes Education for Patients With Type 2 Diabetes in Turkmenistan

The aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in Turkmenistan.

Diabetes education is not routinely carried out in Turkmenistan. The aim of the study is to investigate whether patients with type 2 diabetes benefit from an International Diabetes Federation (IDF) based education program. Patients will be randomized into a education group and a control group. The education group will receive 4 - 5 hours of education and the control group will only receive general information about diabetes mellitus. After 6 months, it is checked whether the change in the HbA1c value differs between the two groups. Additinal paremeters such as blood pressure, diabetes knowledge and lipids will also be evaluated (secondary parameters).

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* type 1 diabetes
* diabetes duration \< 1 year
* severe comorbidities
* abuse of alcohol or drugs
* pregnancy
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia

The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). The investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of Barrett's esophagus.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)

Exclusion Criteria:

-