cyrilzakka/clinical-trials huggingface dataset:
Dose Response Study of Nitisinone in Alkaptonuria

SONIA 1 is an international, multicentre, randomised, open-label, no-treatment controlled, parallel group, dose-response study to investigate the effect of once daily nitisinone on 24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks treatment. They study will identify the optimal dose to decrease urine homogentisic acid to near normal levels.


Eligibility Criteria:
Inclusion criteria

A subject must fulfil the following criteria in order to be included in the study:

1. Diagnosis of alkaptonuria verified by documented elevated urinary homogentisic acid excretion.
2. Age ≥18 years.
3. Willing and able to visit the investigational site for study visits.
4. Signed written informed consent obtained.

Exclusion criteria

The presence of any of the following will exclude a subject from inclusion in the study:

1. Non-alkaptonuria causes of ochronosis.
2. Currently pregnant or lactating.
3. Known allergy to nitisinone or any of the constituents of the investigational product.
4. Use of a protein-restricted diet
5. Dietary habits or use of homeopathic therapies that interfere with tyrosine catabolism.
6. Current keratopathy, contact lens use or uncontrolled glaucoma.
7. Current malignancy.
8. Uncontrolled hypertension (blood pressure greater than 180 systolic or greater than 95 diastolic).
9. Electrocardiogram changes indicative of myocardial infarction, arrhythmia, tachycardia, bradycardia, left bundle branch block.
10. Chest radiographic abnormalities, including an infiltrative, mass, congestive heart failure, embolism, atelectasis.
11. Serum potassium \< 3.0 mmol/L.
12. eGFR \< 60 mL/min.
13. Any hepatic enzymes greater than 3 x upper limit of normal.
14. Haemoglobin \< 10.0 g/dL.
15. Platelets less than 100 x 109/L.
16. WBC less than 3.0 x 109/L.
17. ESR greater than 100 mm/h.
18. History of alcohol or drug abuse.
19. Participation in another clinical trial within 3 months of randomisation.
20. Treatment with nitisinone within 3 months of randomisation
21. Psychiatric illness or neurological disease that interferes with compliance or communication with health care personnel.
22. Any other medical condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
23. Foreseeable inability to cooperate with given instructions or study procedures.
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors

The purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing.

Participants who were diagnosed with Stage I-III colorectal cancer will undergo testing with mt-sDNA followed by a questionnaire about satisfaction with mt-sDNA (multitarget stool DNA panel), prior to their scheduled colonoscopies at years 1 and 4 after diagnosis.

Participants will be asked to provide a stool sample for mt-sDNA (Cologuard) testing that will be collected within 90 days before their scheduled colonoscopy. The kit will be given to the participant by study personnel and mailed back directly to Exact Science.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum
* Receipt of preoperative colonoscopy
* Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated

Exclusion Criteria:

* Stage IV colorectal cancer
* Surgical treatment with subtotal colectomy or total proctocolectomy
* Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis
* Presence of advanced adenomas (1 cm or larger, villous features and/or high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen.
* Inability to provide informed consent
* Inability to understand spoken and written English
* Medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. These would be at the discretion of the participant's providers.
Patient Engagement Study to Evaluate the Use of Biological Therapies for Cardiac Arrhythmias

In this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. Patient Partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.

There will be four study groups:

1. Heart patients who experienced a cardiac arrhythmia while in hospital,
2. Heart patients who did not experience a cardiac arrhythmia while in hospital,
3. Heart patients with an upcoming procedure that have not had a cardiac arrhythmia,
4. Members of the general public.

There will be a presentation, two surveys and a team meeting. Results will be compiled and analyzed.

Eligibility Criteria:
Inclusion criteria:

* Upcoming or previous cardiac procedure.

Exclusion Criteria:

* Inability to complete an electronic survey or participate in a small group meeting.
Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis

Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control.

Main objective:

To establish the effect of core motor control training on pelvic floor functionality in patients with multiple sclerosis.

Specific objective: To assess the effect of core motor control training on urinary incontinence.

* To assess the effect of core motor control training on urinary incontinence in patients with multiple sclerosis.
* To assess the effect of core motor control training on quality of life in patients with multiple sclerosis.
* To assess the effect of core motor control training on sexual dysfunction in patients with multiple sclerosis.
* To assess the effect of core motor control training on balance in patients with multiple sclerosis.
* To test the relationship between respiratory functionality and pelvic floor dysfunctions in patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* - Age between 18 and 70 years.
* Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with an evolution time of more than two years (remitting or progressive) (24).
* Multiple Sclerosis Disability Status Scale (EDSS) score between 2 (minimal disability in one of the functional systems), and 7.5 (inability to take more than a few steps. Limited to wheelchair and transfer support. Ability to move the chair, but not all day if the chair is conventional and lacks a motor) (25, 26).
* Stable medical treatment for at least six months prior to surgery (26).
* Absence of cognitive impairment, with ability to understand instructions and score 24 or higher on the Minimental Test (27).
* Urinary incontinence as a consequence of neurological involvement.

Exclusion Criteria:

* - Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
* Diagnosis of any cardiovascular, respiratory, genitourinary, metabolic or other conditions that may interfere with this study.
* Having presented urinary incontinence prior to the diagnosis of MS.
* Have suffered an exacerbation or hospitalisation in the last 3 months before starting the assessment protocol, or during the therapeutic intervention process.
* Have received a course of intravenous or oral steroids 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.

The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.

The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.

The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)

Eligibility Criteria:
Inclusion Criteria:

* The specimen is from a patient with symptoms of acute gastroenteritis.
* The specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
* The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criteria:

* The specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's disease
* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
Real World Outcomes Using Novel Agents for AML in the UK

This project will collect data on patients with acute myeloid leukemia in the United Kingdom who were treated with two new targeted therapies during the coronavirus pandemic

Acute myeloid leukaemia (AML) is a blood cancer which in fit young adults is typically treated with intensive chemotherapy. While this is potentially curative, it is associated with significant side effects and the requirement for long hospital admissions. Infection is a major issue during AML treatment, as both the disease and the chemotherapy impair the immune system.

Early data suggested that COVID-19 is associated with a very high rate of death in AML patients undergoing intensive chemotherapy. Because of this, and the need for significant hospital resources to deliver intensive chemotherapy, the NHS made available two new, less intensive, targeted therapies for the treatment of AML during the COVID-19 pandemic - venetoclax and gilteritinib. The aim was to reduce mortality and healthcare resource use.

Many hundreds of patients across the UK have been treated with these two medications on the temporary access scheme. The research aims to collect de-identified data from treating patients to describe the outcomes of patients treated with these approaches, both in terms of the safety and effectiveness.

Eligibility Criteria:
Venetoclax cohort Inclusion criteria

1. Newly diagnosed acute myeloid leukaemia
2. No prior therapies for AML, apart from hydroxyurea (or similar) for cytoreduction. Previous treatments for MDS or other conditions are allowed
3. Treated with venetoclax in combination with either azacitidine or LDAC No exclusion criteria

Gilteritinib/FLT3 cohort Inclusion criteria

1. Relapsed acute myeloid leukaemia, including molecular relapse
2. Treated with FLT3 inhibitor No exclusion criteria
A Dose Response Effect of Atomoxetine to the Acute Effects of Alcohol

This two-stage study will examine the effects of a 5 day course of atomoxetine (placebo, 40, 60 or 80 mg/day; Strattera) (a selective NE transporter (NET) inhibitor) on alcohol-elicited craving and sensitivity to alcohol. The novelty of this study is that of atomoxetine and the fact that it targets NET, neither of which has heretofore been examined in the context of alcohol dependence. It is hopeful that this pilot study, of 86 total individuals, will provide the PI with sufficient preliminary data to submit a subsequent R01 application to study atomoxetine and the involvement of specific single nucleotide polymorphisms within the NET gene on alcohol-related phenotypes in alcohol dependent and non-dependent populations. The long-term objective of this research is to develop more efficacious treatment interventions for alcohol abuse and dependence.

Hypothesis 1: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will demonstrate significantly less alcohol-elicited craving than subjects who receive a placebo.

Hypothesis 2: It is hypothesized that subjects who receive 40, 60 or 80 mg/day of atomoxetine for 5 days will be less sensitive to the acute effects of alcohol (subjective intoxication) than subjects who receive a placebo.


Eligibility Criteria:
Inclusion Criterion:

1. Males and females age 21 to 35, as verified upon the presentation of a valid driver's license;
2. Must drink alcohol at least twice a week and have a minimum of 3 drinks per occasion (2 for women);
3. Must score 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT; Babor et al., 1992). The AUDIT is a screening instrument used to identify persons whose alcohol consumption is characterized by moderate to heavy drinking;
4. No history of alcohol treatment or desire for treatment;
5. Not currently take medications that are contraindicated for concurrent use with alcohol;
6. Female subjects must not be pregnant, as indicated by a pregnancy test that will be conducted immediately prior dispensing of medication.

Exclusion Criterion:

Subjects who have hypertension, tachycardia, cardiovascular disease, hepatic or renal impairment, pregnant or who are currently using MAO inhibitors, Albuterol or other pressor agents will be excluded from this study.
Effects of Vitamin B12 on the Body's Internal Clock

Circadian rhythms are 24-hour cycles that influence natural functions in the body such as heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an internal clock and affect sleep patterns. The purpose of this study is to determine the effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.

Individuals with circadian rhythm sleep disorder suffer from recurrent patterns of disrupted sleep that can significantly affect their daily functioning. Evidence suggests that vitamin B12 supplements may have a beneficial effect on sleep patterns. However, research on the effects of vitamin B12 supplements on sleep is limited. This study will determine the effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.

This study will last 47 days. Participants will undergo a 3-week medical and psychological screening prior to study entry. Eligible participants will be admitted to the General Clinical Research Center where they will live in a private study room for the duration of the study. The room will be a time-free environment with no windows, clocks, television, or radio. Participants will not be able to make or receive telephone calls, and their bedtimes, wake times, and mealtimes will be determined by study researchers. Participants will be randomly assigned to receive three capsules of either vitamin B12 or placebo daily. Blood and saliva collection will occur daily to determine core body temperature and hormone levels. Performance tests to determine participants' cognitive abilities will be administered at regular intervals throughout each day. Participants' sleep will be recorded every night with polysomnography, which will monitor brain and muscle activity and breathing patterns during sleep.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of delayed sleep phase syndrome OR self-described as a "night owl"

Exclusion Criteria:

* History of medical illness
* History of psychiatric illness in participant or his or her family members
* Current medication or vitamin use
* Follow a vegan diet
* Significant visual problem
* Recent travel across time zones
* History of rotating shiftwork
Effect of a Unique Web-based Behaviour Change Program on Weight Loss and Cardiovascular Risk Factors

Web- or internet-based programs have the potential to induce and, possibly, help to sustain, significant lifestyle modification. This study will evaluate the effect of a unique interactive web-based behaviour change program on weight loss and cardiovascular risk factors in people who are overweight or obese and at high risk of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Have regular access to the internet, telephone and have an e-mail address.
* Body mass index (BMI) greater than 27 and less than 40
* Sedentary
* Have one or more of the following risk factors associated with cardiovascular disease: Elevated blood pressure ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic; Elevated total cholesterol ≥ 5.0; Type 2 diabetes
* Be willing to refrain from participating in another behaviour change program for the duration of the study

Exclusion Criteria:

* Major health problems including Type 1 diabetes, established CVD, renal and hepatic disease
* Psychiatric problems
* Pregnancy
* Excessive alcohol consumption
The Effect of Compression Stockings During Training on Running Performance

Studies that have examined the effects of compression stocking on athlete's performance have been carried out in a single test, i.e., the athlete's was examined during running/riding/jumping with and without the compression stocking.

Yet, using the stocking during all training session and for longer period of time might further enhance the performance. Compression stocking were found to have a positive effect on the athlete' recovery. We hypotheses that if the athlete will train with the stocking on a regular basis and his/her recovery will improve, it will also improve the performance. In addition, the athlete's body may need an adjustment period to use the compression stocking. As such, the advantages of using compression stocking might only be revealed after training with the socks during a period of time and not just performing the tests/competitions with it.

All runners will be examined for: demographical parameters, time of 5 Km run, distance of forward jumping with two leg.

The sample will be divided into 2 research group: research group - all training with compression stocking and control group -training without compression stocking. Both groups will continue their training program for 8 weeks according to their coach. A second examination for the same tests at the end of the 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Runners with at least 3 years of experience and background in competitions (participated in at least 5 competitions participated).
* Train between 4-5 time per week, for minimum of 40 minutes and a minimum of 8 km per training.
* Running minimum 35 km per week.

Exclusion Criteria:

* Runners who practiced in the past with compression stocking.
* Complains of lower limb pains
* Medical history of lower limb or back surgery.
A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI4736 in combination with tremelimumab to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity of MEDI4736 in combination with tremelimumab in adult subjects with advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Advanced non-small cell lung cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4. Adequate organ and marrow function

Exclusion Criteria:

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
3. Active or prior documented autoimmune disease within the last 2 years.
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. Many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. Some studies in adults show that skin color may also affect the pulse oximeter reading. In this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.

This multisite, prospective, observational study will be conducted in a population of children under 18 years old who are undergoing cardiac catheterization. The primary aim of the study is to quantify pulse oximeter accuracy in children with varying skin colors. Children undergoing cardiac catheterization are a unique population in which to study pulse oximeter accuracy because they have a wide range of baseline arterial oxygen saturations secondary to their cardiac conditions, allowing for evaluation of pulse oximeter accuracy across a range of arterial oxygen saturations. Children undergoing cardiac catheterization are continuously monitored with pulse oximeters and also have direct measurement of arterial blood oxygen via co-oximeter as part of routine care. The results of this study will contribute much needed knowledge about pulse oximeter accuracy in children to better understand potential clinical implications.

Dimensions of skin colors (melanin index, redness etc) will be objectively measured using spectrophotometry. During and after the catheterization procedure, clinical data already collected during the course of clinical care will be recorded by the study team, including pulse oximeter output and arterial blood oxygen saturation measurement obtained during the procedure. The primary outcome of interest is the difference between the pulse oximeter reading and the direct measurement of arterial blood oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Child is between 1 month and 18 years old
* Child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation.

Exclusion Criteria:

* Child previously participated in the study
* Child has differential cyanosis across extremities
* Child is receiving an intravenous vasoconstrictor prior to procedure
* Child has a ventricular assist device (VAD)