cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study

The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to add to this pool of knowledge and also increase the inclusion criteria to include the AASM 2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the investigators will add novel information to the field by assessing the benefits of treatment in both sub-groups of mild OSA.

Patients who visit their local sleep service for OSA investigation, and are found to have mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM 2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).

At the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. Participants will then be randomised to a CPAP treatment group or control group.

After 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.

Eligibility Criteria:
Study Inclusion Criteria

* Aged ≥ 18 and ≤ 80
* Ability and willingness to provide written informed consent
* AHI ≤ 15 as per AASM 2007 scoring criteria
* Ability to tolerate a CPAP one hour long run in test

Exclusion Criteria:

* The presence of unstable cardiac disease
* Inability to give fully informed consent
* Supplemental oxygen
* Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, obesity hypoventilation syndrome
* ESS ≥ 15, or concerns about sleepy driving from physician/ sleep lab staff
* BMI ≥ 40
Study of Safety and Efficacy of MY008211A in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The main purpose of this study is to evaluate the efficacy of MY008211A in adult patients with PNH, showing signs of active hemolysis.

The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients who are naïve to complement inhibitor therapy, including anti-C5 antibody.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
* Mean hemoglobin level \<100 g/L.
* LDH \> 1.5 x Upper Limit of Normal (ULN).
* Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

* Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
* Were using a complement inhibitor before the first administration of MY008211A tablets or had discontinued a previous complement inhibitor for less than five half-lives or 120 days, whichever was the longest.
* History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
* Known or suspected hereditary complement deficiency.
* Previous bone marrow or hematopoietic stem cell transplantation.
* Previous splenectomy.
* A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS

This community-engaged research project will test an adapted online breast cancer screening decision aid to address the needs of women living in an area where environmental contamination has increased concern about breast cancer risk. It will provide novel data on individual experiences with breast cancer risk assessment and decisional determinants of screening choices in a community disproportionately impacted by industrial pollution.

Environmental contamination is increasingly recognized as a critical driver of cancer disparities, and communities impacted by industrial pollution experience greater risk of cancer and higher cancer worry which complicates health decision making. Recently the National Academies of Science Engineering and Medicine (NASEM) released guidance suggesting that per- and polyfluoroalkyl substances (PFAS) are suggestively associated with breast cancer risk and that individuals with moderate to high blood concentrations of these chemicals should screen for breast cancer according to age and other risk factors as recommended by the US Preventive Services Task Force (USPSTF). Mammography screening guidelines for women in their 40s increasingly call for the use of risk assessment tools to guide screening initiation and imaging intervals (e.g. every year vs. every two years), but current tools do not address environmental risk factors that can contribute to breast cancer risk. This poses a particular challenge in communities where there is a real or perceived increased risk of breast cancer stemming from an environmental contamination concern. There are currently no decision tools tailored to help women living in such communities with their decisions about breast cancer screening. Therefore, the goal of the proposed work is to test an adapted online decision aid to incorporate environmental risk messaging to increase informed breast cancer screening decisions for women 40-49 years of age living in the greater Merrimack, New Hampshire area, where known and ongoing PFAS contamination exists. In partnership with Merrimack Citizens for Clean Water, we will distribute a community survey among screening-eligible women to test the new risk messaging within the decision aid (n=100) and establish acceptability in an open-label, single arm trial. The proposed research will contribute novel data on community-driven priorities for information about environmental contaminants that may affect breast cancer risk assessment and screening decisions.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 39-49
* No personal history of breast cancer,
* No mammogram in the prior 12 months
* Resident of Merrimack, Hillsborough, Rockingham or Bennington counties

Exclusion Criteria:

* History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ
* Cognitive impairment impeding the ability to provide informed consent
Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer

In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.

Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.

A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-80 years
* Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery

Exclusion Criteria:

* Patients with distal metastases confirmed at diagnosis
* Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer
* If patients do not agree with this study
Vibration Training in Healthy Individuals

The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.

The aim of the study was to examine the effect of six-week constant, low frequency and low amplitude Whole Body Vibration training on the strength and mechanical properties of the lower limb knee extensors and ankle joint dorsi flexor muscles.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering
* Weight less than 120 kg

Exclusion Criteria:

* The presence of a history of trauma in the lower extremity in the last six months
* Limitation of movement in the lower extremity
* A history of cardiovascular, neurological, orthopedic disease
A Study of the Safety and Efficacy of CNTO 888 in Combination With SoC (Standard of Care) Chemotherapy in Patients With Solid Tumors

The purpose of this study is to evaluate the safety and dose regimen of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens.

CNTO 888 is an antibody that works by blocking a protein called CC-chemokine ligand 2 (CCL2). In research studies CCL2, has been shown to increase the growth of new blood vessels which help the tumor to survive. It is hoped that blocking CCL2 may help to control tumor growth.

Patients will receive one of four treatments. A dose of 15 mg/kg CNTO 888 will be administered once every 3 weeks in combination with either docetaxel, gemcitabine, or paclitaxel-carboplatin in Treatment Arms 1, 2, and 3, respectively; and 10 mg/kg CNTO 888 will be administered once every 2 weeks with DOXIL® / Caelyx® (doxorubicin HCl liposome injection) for intravenous infusion once every 4 weeks in Treatment Arm 4. The maximum time that patients will be in the study is one year.

Safety assessments will be conducted throughout the course of the study. Safety assessments include the monitoring of side effects,clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs, and physical examinations. CNTO 888 will be administered IV at 2 different doses (15 mg/kg or 10 mg/kg) dependant on the chemotherapy combination. Combination therapy will be continued until disease progression, unacceptable toxicity, the patient refuses further combination therapy, withdraws consent, or is treated for 1 year

Eligibility Criteria:
Inclusion Criteria:

* Documentation of an advanced solid tumor
* No more than 2 previous anticancer therapies
* good performance status
* adequate bone marrow, liver, and renal function / adequate blood test values
* willing to use birth control measures

Exclusion Criteria:

* No residual toxicities resulting from previous therapy
* no known allergies, hypersensitivity, or intolerance to antibodies or chemotherapies
* clinically significant bleeding or requiring concurrent therapeutic dose of anticoagulation
Transversus Abdominis Muscular Training and Chronic Low Back Pain

Low back pain is not a diagnosis; it is a symptom describing the presence of pain in the lumbar vertebral or paravertebral region without any reference to the structure or cause of the process. It is one of the most widespread diseases and one of the most common reasons for visits in primary care setting.

Exercises to improve lumbar stability involving co-contraction of the transversus abdominis have proved to be effective in reducing pain and improving function. It has been stated by ultrasound images that specific stabilization exercises cause contraction of the deep abdominal muscles, but it remains unclear whether training produce thickness muscle improvement and if this improvement is related to clinical findings.

To try to resolve this issue a project of an experimental trial, double-blind (patient and evaluator) with two groups randomly assigned is presented. All participants will be recruited in an primary care center of the Catalan Health Institut and will sign informed consent. All will receive a protocolized treatment with therapeutic exercises and thermotherapy and, additionally, those assigned to the intervention group were instructed in performing lumbar stability exercises.

Pain (VAS), function (Roland-Morris Questionnaire) and the thickness of the transversus abdominis, internal and external oblique muscles (measured by ultrasound) at baseline, end of treatment protocol (12 sessions) and three months after the end of treatment will be assessed.

Results in pain, function, and its correlation with the mean changes in the thickness of transversus abdominis will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over
* Diagnosis of chronic low back pain (over 3 months)
* Sign the informed consent form.

Exclusion Criteria:

* Non-stand supine position
* Neural Irradiation pain
* Previous surgical intervention in low back region
* Heart pathology
* Pregnancy
* Pending litigation or legal claim
* Poor language and communication skills making difficult to understand the informed consent
Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.

We proposed a bicentric study cohort of obese patients (BMI \> 40 kg/m2) treated by 1 day injection of Fondaparinux 2.5 mg after bypass surgery. Anti-Xa activity of Fondaparinux will be measured 4 times during hospitalisation for each patient to realise a pharmacokinetic modelisation of Fondaparinux. Haemorrhage and thromboembolics events will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* requiring a bariatric surgery
* requiring an antithrombotics prophylaxis
* having a morbid obesity based on a BMI \>40 kg/m2
* having signed the inform consent form

Exclusion Criteria:

* contra-indication to fondaparinux
* history of heparin induced thrombopenia (HIT)
* platelets \< 100 G/l
* requiring an effective antithrombotic treatment
The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population

The main objective of this project is:

1. To assess the influence of physical fatigue on brain functioning during a balance and reaction time task in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).

The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Twenty healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked.

Next, the subjects will carry out a Y-balance test and a balance reaction-time test. Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same Y-balance test and balance reaction time test, and fill in the SRPE scale one more time. Heart frequency and EEG will be measured continuously during the trials.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
* Male and female
* No medication
* Non-smoker
* Between 18 and 35 years old

Exclusion Criteria:

* Back and/or lower extremity injuries during the past 6 months
* Bone/joint abnormalities
* Dizziness, history of loss of consciousness, any inner ear disorders
* Nervous system disorders or dysfunctions
* Uncorrected eye disorders/dysfunctions
* Illness
* Use of medication or any kind of drugs
* Use of alcohol, caffeine and heavy efforts 24 hours before each trial
* Not eating the same meal the night before and the morning of each experimental trial
TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051

This is an observational, "ancillary study" intended to describe opioid use among opioid use disorder patients following their discharge into the community from inpatient detoxification and/or short-term residential treatment programs affiliated with parent study CTN-0051, which assessed the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

Participant recruitment will begin after recruitment for CTN-0051 has been completed. Opioid use disorder patients will be recruited prior to leaving detoxification and/or short-term residential programs. Screening and baseline data (focused on demographics, diagnosis and service utilization) will be collected prior to discharge, and follow-up data (focused on opioid use) will be collected at weeks 1, 4 and 8 following discharge.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* Meet DSM-5 criteria for opioid-use disorder (heroin or prescription opioids);
* Have used opioids other than as specifically prescribed within thirty days prior to consent
* Seeking treatment for opioid dependence;
* Able to provide written informed consent;
* Able to speak English sufficiently to understand the study procedures.

Exclusion Criteria:

* Serious medical, psychiatric or substance use disorder that, in the opinion of the Site PI, would make participation hazardous to the participant, compromise study findings or prevent the participant from completing the study;
* Suicidal or homicidal ideation that requires immediate attention;
* Maintenance on methadone at doses of 30mg or greater at the time of signing consent;
* Presence of pain of sufficient severity as to require ongoing pain management with opioids;
* Pending legal action or other reasons that might prevent an individual from completing the study;
* If female, currently pregnant or breastfeeding or planning on conception;
* Prior participation in parent trial CTN-0051
Safety Study of BLS-M22 in Healthy Volunteers

BLS-M22 is being developed as an anti-myostatin agent for the treatment of Duchenne Muscular Dystrophy (Muscular Dystrophy). A total of 37 subjects participated in this study to confirm the safety of BLS-M22.

This study is a dose Block-randomized, Double-blind, Placebo-controlled and Dose-escalation Phase I Clinical Trial to Evaluate Safety of BLS-M22.

The single ascending dose group participated in 9 patients in each group(500mg, 1,000mg, 2000mg/BLS-M22 or Placebo(n=7:2)). The multiple ascending dose group participated in 10 patients(determined dose in SAD/BLS-M22 or Placebo(n=8:2)).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between 19-55 years of age
2. BMI: 19\~28kg/m2(male), 18\~25kg/m2(female) at screening test
3. Able to provide consent to participate and having signed an Informed Consent Form (ICF)
4. The subjects can obey the demands of the scheme

Exclusion Criteria:

1. Subject has a clinically significant disease or history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, digestive system, respiratory system, neuropsychiatry, blood∙tumor system.
2. Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug
3. Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization
4. Subject has received steroids or other immunosuppressive drugs within 30 days of randomization
5. Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis
6. Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm
7. Pregnant women
8. Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
9. Subject has abnormal clinical laboratory test results
10. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Renin and Renal Biomarker Response to Angiotensin II

Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Medical ICU admission
* Septic shock
* Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)
* Kidney Disease Improving Global Outcomes stage 1 or greater Acute Kidney Injury

Exclusion Criteria:

* Prisoner
* Pregnancy
* Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree
* Purely cardiogenic shock (no distributive component)
* Mesenteric ischemia
* Acute ischemic stroke
* Hemorrhagic shock
* Active treatment of hepatorenal syndrome targeting a Mean Arterial Pressure = 65 mm Hg
* Planned withdrawal of care within next 24 hours or no escalation of care
* Patient enrolled in an interventional study
* High likelihood of medical futility in using this drug:
* 3 or more vasopressors required to sustain MAP
* Sustained norepinephrine equivalents \> 0.5 mcg/kg/min
* COVID-19 positive, or high suspicion of COVID-19