cyrilzakka/clinical-trials huggingface dataset:
Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum

The aim of this study is to validate two new biomarkers in sputum samples. These are PiP3 (phosphoinositolphospat ) and phosphor proteins, representing important proteins within inflammatory situations of the lung.

Within the study, sputum samples will be collected at 3 repetitive occasions in a 3 week interval of the different donors.

The objective is to assess for biomarker specificity and reproducibility in the two groups (smokers and non-smokers). The methods for measurement shall be validated by repetitive measurement of the sputum samples, i.e. comparison of multiple measurements of the same sample and comparison of different samples from the same donor.

Eligibility Criteria:
Inclusion Criteria:

* • Healthy male and female subjects, aged 25-45 years. Women will be considered for inclusion if they are not pregnant, as confirmed by pregnancy test and not nursing.

Females of childbearing potential need to use a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first visit until at least 72 hours after the last visit -, implants, injectables, combined oral contraceptives, hormonal IUDs (intrauterine device) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).

* Body weight ≥ 50 kg and BMI (body mass index) within the range 19-32 kg/m²
* Smokers need to consume at least ten cigarettes per day and need to have at least ten packyear
* Non-smokers need to be non-smoking since at least a year with a smoking history of no more than 1 packyear.
* FEV1 (forced expiratory volume at one second)≥80% predicted and FEV1/FVC (forced expiratory vital capacity) ≥70%

Exclusion Criteria:

* • History of an acute infection four weeks prior to the informed consent visit.

  * Regular intake of medication.
  * Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
  * Participation in another clinical trial 30 days prior to enrollment.
A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

This clinical trial develops and tests a culturally-appropriate educational program (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice. Increased sugar consumption may lead to an increased risk of chronic diseases, including obesity, diabetes, some types of obesity-related cancers, coronary heart disease, hypertension, and dental decay. A culturally sensitive program may help reduce sugar-sweetened beverage consumption in Native American men

PRIMARY OBJECTIVE:

I. Conduct and analyze qualitative data from focus groups and key informant interviews with Native American community members including Native American leaders and community members to develop Sugar Sweetened Beverage (SSB) intervention for Native American men (SIPsmartER Lacrosse).

OUTLINE:

AIM 1: Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement.

AIM 2: Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications twice a week (BIW) for 12 weeks and then monthly thereafter up to month 6.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years or older
* Research conducted on tribal lands require tribal government approval. Our project will not be occurring on tribal lands. The project will be working with Native organizations off-territory
* Participants only must own a smart device in order to receive study text messages
* At least 18 years or older
* Research conducted on tribal lands require tribal government approval. Our project will not be occurring on tribal lands. The project will be working with Native organizations off-territory
* Participants only must own a smart device in order to receive study text messages

Exclusion Criteria:

* Research conducted on tribal lands require tribal government approval. Since we do not currently have tribal government approval, our project will not be occurring on tribal lands
Neuromuscular Ultrasonography Utility for Detection of Peripheral Neuropathy in Systemic Lupus Erythematosus

This study aims to evaluate the rule of NMUS in detection of peripheral neuropathy in SLE patient and to correlate it to traditional neurophysiological studies, clinical signs and activity of SLE.

The frequency of SLE peripheral neuropathy documented by electrophysiology has been estimated to be approximately 30%.

The term peripheral neuropathies include symmetric polyneuropathy, single and multiple mononeuropathy, and radiculopathy.

There has been increasing interest in using ultrasonography (US) to aid peripheral neuropathy diagnosis and studies have shown good correlation with other imaging modalities. US is a non-invasive and inexpensive imaging device that has become widely available as a diagnostic tool at many fields.

so systemic lupus patients were enrolled in the study , performed nerve conduction study and neuromuscular ultrasound for bil. median, ulnar, peroneal, tibial and sural nerves , on statistics the cross sections were compared in neurophusiologically affected and non affected nerves, also the sensitivity and specifity of NMUS in comparison to the traditional NCS was calculated

Eligibility Criteria:
Inclusion Criteria:

1. All adult SLE patients who was admitted to Rheumatology \& Rehabilitation department of Assuit university hospital during time frame of study.
2. apparently healthy subjects with normal electrophysiological study
3. verbal consent, free and informed

Exclusion Criteria:

* • Other causes of peripheral neuropathy:

  1. Traumatic
  2. Purely degenerative
  3. Diabetic
  4. Toxic
  5. Infections
  6. Drug induced
BALANCED GROWTH: The Involvement of the Vestibular System in a Child's Cognitive and Motor Development

When a vestibular dysfunction occurs at birth or in early stages of life, one might expect that this may have an enormous impact on a child's development. It is known that a severe congenital or early acquired vestibular deficit in children results in delayed psychomotor milestones. Later in life, children with a vestibular dysfunction may have difficulties with several balance tasks and additional cognitive, motor and/or psychosocial performances. While a few authors have suggested that there is indeed an influence of a vestibular dysfunction upon these different developmental domains (cognitive, motor, educational and psychosocial development), which can be supported by findings in clinical practice as well, literature concerning this topic remains fairly limited. On the other hand, several studies have shown that children with known difficulties in motor and/or cognitive functions have more difficulties in vestibular performances in comparison with their unaffected peers. Although more frequently discussed, the literature on this population is rather scarce too.

Therefore, the current project aims to investigate the relationship with and the involvement of the vestibular system in the motor and cognitive development of school-aged children.

General goals

1. Developing and standardizing a sensitive and specific test protocol for the detection of vestibular, cognitive and/or motor dysfunctions in school-aged children.
2. Investigate the relationship with and the involvement of the vestibular system in the motor and cognitive development of typically developing school-aged children.
3. Investigating whether a vestibular dysfunction (with/without an additional auditory disease) has an impact on motor and/or cognitive performances in school-aged children.
4. Investigating if in children with a known neurodevelopmental disorder an (additional) underlying vestibular dysfunction can be identified.

Eligibility Criteria:
For typically developing children

Exclusion Criteria:

* Having a (permanent) hearing loss
* Having a (permanent) vestibular loss
* Having a motor dysfunction
* IQ \< 70

For vestibular-impaired children

Inclusion Criteria:

* Recently (\< 6 months) tested at the Ghent University Hospital
* Diagnosed with a vestibular impairment (= alteration on at least one of the vestibular function tests: caloric, rotatory chair, vHIT, cVEMP and/or oVEMP test)

For neurodevelopmental group

Inclusion Criteria:

• Diagnosed by a (neuro)psychiatric team with Autism Spectrum Disorder, Attention deficit/Hyperactivitiy Disorder and/or Developmental Coordination Disorder
Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination.

To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Diagnosis of rumination by RomeIII criteria

Exclusion Criteria:

1. Active alcohol or substance abuse
2. Presence of a depressive disorder as measured by PHQ-9 score of 10 or above
3. Presence of clinical significant anxiety disorder as measured by GAD-7 score of 10 or above.
4. Severe levels of health focused anxiety as measured by SHAI score of 26 or above.
5. Any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures.
6. Any active psychosis or suicidality.
The Effect of Dietary Sugar Consumption on Sweet Taste Perception

The purpose of the study is to determine how reducing the amount of simple sugars in the diet affects sweet taste perception. Healthy adult subjects will be assigned to either follow their usual diet, or to replace sugar calories with fats or starch.

The investigators hypothesize that eating less sugar will:

1. cause foods and drinks with a given amount of sugar to taste sweeter
2. cause people to prefer lower levels of sugar in foods and drinks


Eligibility Criteria:
Inclusion Criteria:

* Good general heath (by self report)
* Consume at least 2 sugar-containing soft drinks/day on average)
* Able to control diet (select their own foods)

Exclusion Criteria:

* Major illness of any kind within the last six months, or any chronic illness
* Daily use of medication, except for birth control, vitamins, and aspirin
* Regularly consume non-nutritive sweeteners
* Pregnant women
* Gained or lost 10% or more of their body weight in the last 3 months
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Post COVID-19

This study is an early feasibility study to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of continuing respiratory distress after recovery from COVID-19.

The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of continuing respiratory distress after recovery from COVID-19.

The primary objective of this study is to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from initial COVID-19 infection.

The secondary objective is preliminary assessment of feasibility of a single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects that are ambulatory and previously hospitalized for a confirmed diagnosis of COVID-19 using RT-PCR test
2. Male or female subjects between the ages of 18-75
3. SpO2 \> 92% on room air
4. Subjects with BMI ≥22
5. Subjects with Forced Vital Capacity (FVC) ≥ 40% predicted and ≤ 70% predicted
6. Subjects with DLCO ≥ 20% predicted and ≤ 70% predicted
7. Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study before any study procedures are performed
8. Subjects with the ability to speak, read and understand English
9. Subjects with the ability to complete follow up as specified in the protocol

Exclusion Criteria:

1. Subjects taking immunosuppressive drugs
2. Subjects with history of lung malignancy
3. Subjects allergic to lidocaine or epinephrine
4. Women that are pregnant or planning to become pregnant during the study
5. Women that are lactating
6. Women on hormonal contraceptives in the past 30 days
7. Women currently on hormone replacement therapy
8. Subjects with chronic kidney disease Stage 4 and Stage 5
9. Subjects with a history of pulmonary embolism
10. Subjects with a history of anti-phospholipid syndrome
11. Subjects participating in any other clinical study
12. Subjects with history of deep vein thrombosis
13. Subjects with history of Cirrhosis with Pugh classification of B or C
14. Subjects on hemodialysis
15. Subjects with organ dysfunction or predisposed to organ dysfunction (i.e., pre-dialysis \& orthopnea)
16. Subjects with a history of prior clotting disorders or thrombotic syndrome
17. Subjects with myocardial infarction within the past 2 months
18. Subjects with blood pressure \<85/50 mmHg or \>160/100 mmHg or mean arterial pressure \<60 mmHg or \>120 mmHg
19. Subjects with a history of drug or alcohol abuse
20. Pulse \<50 bpm or \>140 bpm
21. Cardiac rhythm showing rapid atrial fibrillation with heart rate \>120 bpm or ventricular tachycardia
Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.

Colistin is an antibiotic active against several classes of multi-resistant gram-negative bacteria; the drug should be used in high doses in patients on continuous renal replacement therapy, since the drug is eliminated through the dialysis filter.

This is an Open-label, Phase 4, interventional, prospective, single-center pilot study aimed to analyze the concentrations of colistin in plasma and ultrafiltrate by liquid chromatography/mass spectrometry, in 20 critically ill patients admitted to intensive care and suffering from severe infections by multi-resistant bacteria, who receive continuous renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Infection where the involvement of MDR germs is documented or highly probable
* Continuous renal replacement therapy
* Acute renal failure, stage III of the 2012 KDIGO classification
* Half-life of the continuous renal replacement therapy filter less than 48 hours.

Exclusion Criteria:

* State of pregnancy or breastfeeding, or patients expecting to conceive children within the projected duration of the study, starting with the screening through 30 days after the last dose of IMP treatment
* Patients with a positive urine pregnancy test within 72 hours prior to study drug treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
* Women of childbearing potential
* Refusal of informed consent
* Known hypersensitivity to polymyxins and to excipients
* Clinical condition with high probability of death, according to Symplified Acute Physiology Score (SAPS II)
* Partial maintenance of renal function, defined by stages I and II of the 2012 KDIGO classification.
* Renal replacement therapy filter other than AN69 ST 150
* Prior systemic treatments with any investigational agents within 4 weeks prior to the inclusion in the trial
* Any other clinical condition that, in the opinion of the investigator, makes the patient unfit for the trial
Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.


Eligibility Criteria:
Inclusion criteria

* male or female between 18 and 75 years of age at the time of enrollment
* undergoing first-time radiofrequency ablation for left ventricular outflow tract ventricular arrhythmias
* written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

* ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later)
* ventricular arrhythmias not originating from cardiac outflow tracts
* baseline hyponatremia (serum sodium level \< 135 mEq/L)
* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
A Long-term Extension Study of Ustekinumab in Pediatric Participants

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab


Eligibility Criteria:
Inclusion Criteria:

* Must have completed the dosing planned in the primary pediatric ustekinumab study
* Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
* Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
* Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration

Exclusion Criteria:

* Are pregnant, nursing, or planning pregnancy or fathering a child
* Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 \[COVID-19\]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
* Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 \[COVID-19\]) is not automatically an exclusion criterion and must be discussed with the medical monitor