cyrilzakka/clinical-trials huggingface dataset:
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.


Eligibility Criteria:
Inclusion Criteria:

* 6 months old children born at term
* written consent from parents

Exclusion Criteria:

* frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
* gastrointestinal surgery
* cow's milk protein allergy
* metabolic diseases (diabetes or lactose intolerance)
* immune deficiency
* antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
* Life expectancy more than12 weeks
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Known brain metastasis
* Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
* Major surgical procedure within 4 weeks of start of screening procedures
* Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months
Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease

This clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential side effects.

Subjects will undergo surgical transplantation of the dopamine-producing cells under general anesthesia into a part of the brain called the putamen. Subjects then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. Safety, tolerability, evidence of cell survival (using MRI and PET scans of the brain), and effect on Parkinson's disease symptoms are assessed for 2 years post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-78 years old (Canada)
* Age 60-78 years old (United States)
* Diagnosis of Parkinson's Disease made between 3 to 20 years ago
* Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
* Able to participate in all study visits and evaluations, including brain MRI and PET scan
* Existence of a study partner who may act as potential surrogate over long term for ongoing consent

Exclusion Criteria:

* Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease
* Prior Deep Brain Stimulation , lesion therapy, or gene therapy for PD
* Prior surgical or radiation therapy to the brain or spinal cord
* Any medical condition resulting in high risk of immunosuppressive drugs, including any active infectious disease
* Inability to temporarily stop anti-platelet agents or other anti-coagulant medications without serious risk
* Previous or currently active malignant disease within the past 5 years, except basal cell carcinoma or in situ uterine cervical carcinoma that have been treated
* Severe obesity (\>350 lbs) or any condition that prevents use of PET/MRI
* Pregnancy or breastfeeding
* Contraindication to surgery or general anesthesia
* In the opinion of the investigator, any other condition regarded as making subject unsuitable for trial
Examining Self-tracking Behaviors in a Mobile Intervention for Binge Eating and Weight Management

The purpose of this study is to understand users' experiences and interests completing self-tracking in a mobile intervention for binge eating and weight management.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older
* Obesity (BMI ≥30)
* Recurrent binge eating (≥12 episodes in the past 3 months)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Willing to practice self-monitoring
* Has access to a scale
* Not pregnant
* English-speaking

Exclusion Criteria:

* None
Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed.

The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.

Refer to Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Documented sickle cell disease
* Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization.
* Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization
* Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)
* Parental/patient consent and child assent

Exclusion Criteria:

* Primary diagnosis other than vasoocclusive pain
* Concurrent Acute Chest Syndrome (ACS)
* Patient previously enrolled in this study
* Inability to understand English
Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation

Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation.

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Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation.

The proposal of this study is to assess the feasibility and the impact of infrared/near-infrared (IRD) light on the performance of video-laryngoscopy and reduction of the time needed for endotracheal intubation and increase the credibility of the device.

Data-collection will be started after induction of the anesthesia and ended at the confirmation of endotracheal tube position

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* General anesthesia that needs endotracheal intubation
* All Mallampati score 1-3
* ASA physical status 1-3

Exclusion Criteria:

* Refuse or unable to sign the consent.
* Pregnancy
* Emergency cases
* History of or expected difficult intubation
* Maxillofacial abnormality or trauma
* Age below 18 years
* Rapid sequence induction
* Skin disorders and skin light sensitivity (SLE, Lupus ....)
* Impaired head and neck mobility
* Scars or skin injuries at the neck
Digital Therapeutics on Inhalation Medication Adherence in COPD

Digital Therapeutics (DTx) is an evidence-based，clinically evaluated software to treat，manage，and prevent a broad spectrum of diseases and disorders according to Digital Therapeutics Alliance，which may improve the adherence of patients with chronic obstructive pulmonary disease (COPD) to use inhaled medication and reduce the risk of acute exacerbation. This study plans to carry out a randomized controlled trial (RCT), using digital therapy to record and manage the behavior data of patients with COPD in the process of using inhaler medication, and analyze the correlation between digital therapy of COPD and patients' drug compliance and treatment effect.

Chronic obstructive pulmonary disease (COPD) is a major disease that causes death and disability worldwide. The World Health Organization (WHO) estimates that COPD has become the third leading cause of death worldwide, accounting for 6% of the global total deaths in 2019. COPD seriously affects the quality of life of patients and causes heavy economic burden to society and families.

Inhaled medication is the key treatment for COPD, and the adherence of inhaled medication is closely related to the effect of disease control. Studies have shown that incorrect and irregular use of metered-dose inhaler are very common in patients.Previous studies have shown that patients using mobile phones to record respiratory symptom diaries, and send blood oxygen saturation, heart rate, body temperature and other data, as well as changes in medication and medical treatment to the portal, and doctors access the data online to identify potential acute exacerbation and take intervention measures, can reduce the risk of acute exacerbation of COPD.

The digital therapeutics of COPD consists of patient mobile phone program, doctor management software and intelligent medication recorder. It develops a digital intervention plan for patients, helping patients intuitively and comprehensively understand the treatment plan and how to act through medication tracking reminder. It also helps doctors to view visualized patient medication, symptoms and other trend data online to understand the real treatment response of patients. This study take digital therapeutics as intervention to explore the correlation between digital therapy and patient medication adherence and treatment effect.

Eligibility Criteria:
Inclusion Criteria:

1. Fully understand and willing to sign the written informed consent;
2. Local residents diagnosed COPD by physician;
3. Aged 40 and above;
4. Plan to receive metered-dose inhaler as long-term treatment;
5. Have a smartphone and can apply WeChat applet after training;

Exclusion Criteria:

1. Certain comorbidities (e.g. unstable coronary complications);
2. Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months;
3. Pregnant or lactating women;
4. ABS allergy history.
Gardasil Knowledge

Human papillomavirus (HPV) is the most common viral genital tract infection. The majority of women and men who are sexually active will be exposed to a strain or strains of the virus. While there are hundreds of viral strains, high risk strains are associated cervical and oral cancers. According to the Centers for Disease Control (CDC), between 2008 and 2012 there were 38,793 deaths attributed to HPV related cancers. Vaccinations were created in an attempt to prevent infection from the most common high risks strains of HPV. Gardasil/HPV-9 was created to help prevent HPV related cancers and warts. The HPV-9 vaccine includes protection from 7 strains of HPV associated with 74% of HPV related cancers. While Gardasil was approved and released in 2006, many men and women have not been vaccinated. A national immunization survey in 2011 of teens 13-17 years old noted that only 60% of girls and 40% of boys have received at least one vaccination in the series. While complete vaccination series is recommended, a recent study found that a single dose of Gardasil when compared to placebo created a higher level of serum antibodies in uninfected females.

All patients seen at a single clinic will be offered participation in the anonymous survey. The survey will ask a series of questions regarding basic demographics, sexual history, smoking status, and Gardasil vaccine knowledge. The survey will serve as evidence of the vaccine utility by highlighting patient risk factors for HPV and patient knowledge about the vaccine series.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18-26 will be offered participation

Exclusion Criteria:

* Not meeting the inclusion criteria
Assessment of Low Level Laser Therapy Effect on Treatment Outcomes of Bony Supported Distal Jet for Correction of Angle Class II Malocclusion (Randomized Clinical Trial)

The goal of this randomized clinical trial is to compare the effect of LLLT in adolescent patient with class II malocclusion. The main question it aims to answer is:

• is there a difference in the amount of distalization between laser and control groups? Participants will received bony supported distal jet. Researchers will compare laser group with control group to see if there is a difference in amount of distalization between groups.

The aim of the present study is to assess the effect of low level laser therapy on treatment outcomes of bony supported distal jet for correction of 20 orthodontic patients with angle class II malocclusion. enrolled patient is randomly divided into 2 groups laser group and distal screw group. for result assessment dental casts and CBCT are taken before and after completion of distalization. both groups receives Distal Jet supported on 2 paramedian screw with laser therapy for laser group only.

Eligibility Criteria:
Inclusion Criteria:

* bilateral Angle's Class II malocclusion minimum of 1/4 cusp discrepancy, normal or low mandibular plane (MP) angle cases and no history of serious medical illness

Exclusion Criteria:

* subjects with skeletal Class II with retrusion mandibular profile, vertical growth pattern and steep mandibular plane angle and subjects with shallow or anterior open bite.
Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 18 years of age and above
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to cherries or blueberries
* Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
* Not regularly taking medication or antioxidant supplements
A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

This study of NicaPlant® is conducted in patients who have a subarachnoid haemorrhage. Patients will be randomized in two treatment groups. Both groups will receive the standard of care and the investigational group will receive in addition NicaPlant®. NicaPlant® is tested to reduce the long-term complications of aneurysmal subarachnoid haemorrhage (aSAH).

This is a safety, tolerability, efficacy and pharmacokinetic study of NicaPlant® in subarachnoid haemorrhage patients involving two treatment groups. Both treatment groups will receive standard of care and patients randomised to the investigational group will receive in addition NicaPlant® .

NicaPlant® is a nicardipine modified-release formulation. It is presented in the form of a rod-shaped implant with a 4 mg nicardipine load. Following aneurysm clip ligation, 10 NicaPlant® implants will be placed into the basal cisterns in direct contact with the exposed cerebral blood vessel walls.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained according to the Country regulation.
* Male or female patients aged 18 to 75 years (inclusive).
* World Federation of Neurological Surgeons (WFNS) grade III-IV.
* Ruptured saccular aneurysm, confirmed by angiography.
* Onset of aSAH clinical symptoms within the preceding 48 hours.
* Treatment of aneurysm via surgical clip ligation within 72 hours of aSAH is achievable.
* Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use adequate birth control up to 12 weeks after implantation of the study drug. Female patients are considered to be not of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 2 years without a natural menstrual cycle. Male patients must agree to use adequate birth control up to 12 weeks after implantation of the study drug.

Exclusion Criteria:

* SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm).
* World Federation of Neurosurgery (WFNS) grade I, II and V patients.
* Pregnant or Lactating Women.
* Intraventricular or intracerebral blood, in the absence of subarachnoid blood.
* Treatment of aneurysm via endovascular embolisation.
* Presence of moderate or severe vasospasm on screening angiography.
* Any known or CT /MRI evidence of previous major cerebral damage
* Evidence of a cerebral infarction with neurological deficit on pre-treatment CT/MRI.
* History of malignant disease (except for non-melanoma skin cancer) within the previous 5 years or any history of malignant brain tumours or brain metastasis.
* Patients who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomisation.
* Patients with known allergy for Poly(D,L-lactide-co-glycolide) (PLGA) or nicardipine.
* Major complication during aneurysm repair such as, but not limited to, massive intraoperative haemorrhage, brain swelling, or inability to secure the ruptured aneurysm.
COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection

Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.

The investigators will develop novel primers to detect single virus particles in patient samples. The method involves the absorption of light by single virus particles giving a specific pattern. The investigators will develop the device to create a microdroplet of carrier fluid that is run through the trial device. The investigators will develop novel binding receptors for preferential capture of Coronavirus.

The investigators will review the results of the novel test against the standard diagnostic test and identify virus particles in test negative subjects.

The investigators will isolate the viral rna in test negative subjects and perform sequencing to find novel mutations that are not detected by the current test.

Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion of coronavirus or staff member having a coronavirus test

Exclusion Criteria:

* unable to give written informed consent
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.

See uploaded study protocol

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
3. Confirmed non-CF bronchiectasis by (HR)CT
4. Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
5. No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
6. Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus within 12 months.
7. Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
8. Tolerance of inhaled tobramycin

Exclusion Criteria:

1. Any exacerbation within the month prior to the start of the study
2. Diagnosis of cystic fibrosis
3. Active allergic bronchopulmonary aspergillosis (ABPA)
4. Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
5. Any IV or IM corticosteroids or change in oral corticosteroids (\> 10 mg) within 1 month prior to the start of the study
6. Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
7. Change in physiotherapy technique or schedule within 1 month prior to the start of the study
8. Severe immunosuppression or active malignancy
9. Active tuberculosis
10. Chronic renal insufficiency (eGFR \< 30 ml/min), use of loop diuretics
11. Have received an investigational drug or device within 1 month prior to the start of the study
12. Serious or active medical or psychiatric illness
13. Pregnancy and child bearing
14. History of poor cooperation or non-compliance
15. Unable to use nebulizers
16. Allergic for tobramycin
Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults

To compare the effects of aerobic, resistance and combined training in hypertensive obese patients


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive with BP greater than 140/90 mmHg
* Overweight and obese adults with BMI (25-40)
* Physically inactive from past 6 months assessed with pedometer. Those with step count of less than 7000 will be included
* To be able to exercise (6MWT),t hose who completed the test without any symptom

Exclusion Criteria:

* Any active systemic illness that restricts exercise
* People doing exercise on regular basis
* Any cardiopulmonary , metabolic and neurological illness