cyrilzakka/clinical-trials huggingface dataset:
A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of clinically definite relapsing remitting MS (RRMS)
2. Age 45 years and older
3. Willing and able to provide written informed consent
4. Patient has high disease activity.
5. Patient is about to begin Natalizumab (Tysabri) therapy.

Exclusion Criteria:

1. Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS
2. Known infectious or hematological disease.
3. Unwilling or unable to comply with the requirements of this protocol
4. Subject can not have a gadolinium enhanced MRI
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted

The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).


Eligibility Criteria:
Inclusion Criteria for Cohort A and B:

* Written informed consent must be obtained before any assessment is performed
* Male and female patients between the ages of 18 to 65 (inclusive) at screening
* C3G patients wit proteinuria
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* At screening and baseline visits, patients must weigh at least 35 kg
* Supine vital signs should be within the following ranges :

oral body temperature between 35.0-37.5 °C systolic blood pressure, 80-170 mm Hg diastolic blood pressure, 50-105 mm Hg pulse rate, 45 - 100 bpm

.

Inclusion Criteria for Cohort A:

* Estimated GFR (using the CKD-EPI formula) or measured GFR ≥30 mL/min per 1.73 m2 for patients on a maximum recommended or maximum tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
* UPCR ≥ 100 mg/mmol (equivalent to ≥ 1 g/24h total urinary protein excretion)
* Prior to entry, all patients must have been on supportive care including a maximally tolerated dose of ACEi or ARB for at least 30 days.

Inclusion Criteria for Cohort B:

* No histological/laboratory/clinical signs of allorejection
* If applicable, induction treatment after allotransplantation needs to be completed \>30 days before inclusion.
* Transplantation of a kidney allograft \>90 days before inclusion
* Patients need to be on a stable dose of immunosuppressive regimen prior to inclusion. Any approved treatments are allowed for this purpose.

Exclusion Criteria for Cohort A and B:

* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of randomization, or within 30 days, whichever is longer; or longer if required by local regulations
* A history of clinically significant ECG abnormalities,
* Known family history or known presence of long QT syndrome or Torsades de Pointes
* Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug.
* History of immunodeficiency diseases, or a positive HIV test result.
* Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
* Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H. influenzae
A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese males aged ≥20 and ≤40 years of age
* Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator.
Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease

Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply

Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period.

Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation.

Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.

Eligibility Criteria:
Inclusion Criteria:

* term (37-42 weeks gestation) newborns
* pre- or postnatally diagnosed critical congenital heard disease (CHD)
* admitted to the pediatric cardiac intensive care unit at the Children's Hospital of Tübingen

Exclusion Criteria:

* birth weight \<2 kg
* history of neonatal depression (5-min APGAR\<5, cord blood pH\<7.0, sepsis, or birth asphyxia)
* perinatal seizures
* evidence of end-organ injury
* preoperative cardiac arrest
* significant preoperative intracerebral hemorrhage such as grade 3 or 4 intraventricular hemorrhage.
A Neurocognitive and Immunological Study of a New Formula for Healthy Infants

To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Full-term newborns (\>37 weeks and \<41 weeks gestation)
* Adequate birth weight for his gestational age (between 3-97 percentiles)
* Inclusion age: from 0 to 2 months (60 days) in the formula fed groups
* Inclusion age: 2-6 months (180 days) in the breastfeeding group
* Maximum 30 days of exclusive breastfeeding in the formula fed groups
* From 30 days on, exclusive or \>70% infant formula in the formula fed groups
* Normal Apgar score: 7-10
* Umbilical pH ≥ of 7.10
* Availability to continue during the whole study period
* Informed consent signed ( parent/legal representative)

Exclusion Criteria:

* Participating in other studies.
* Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...).
* Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance)
* Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex.
* Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment.
* Infant's family who in the investigators assessment cannot be expected to comply with the protocol.
MBSR and NLP, Postpartum Breastfeeding and Depression

The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.

The postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. Studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. As important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. However, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation.

When the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.

Eligibility Criteria:
Inclusion Criteria:

* 19-35 years old
* caesarean section
* primiparous
* breastfeeding women

Exclusion Criteria:

* women who refused to participate in the research.
Symptom Tracking in Long COVID Patients Using Formula C™ Sublingual Drops

This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. During that time, participants will answer weekly surveys to track symptoms and wellbeing.

Long COVID is a global health crisis with no current treatments. There's a growing interest within the medical community to explore the potential benefits of full hemp flower extracts in treating and alleviating Long COVID symptoms. Full hemp flower extracts are a remarkable advancement in the field of natural wellness and healing. Full hemp flower extracts harness the full spectrum of beneficial compounds present in the hemp plant, including not just cannabidiol (CBD), but a host of other cannabinoids, terpenes, and flavonoids. This process, known as 'whole plant' or 'full spectrum' extraction, produces a more potent and therapeutic product, as the various compounds work synergistically in what is referred to as the 'entourage effect'. These extracts have been associated with a broad range of potential health benefits, such as pain relief, reduction of inflammation, anxiety management, and sleep improvement. A recently published single-blind, randomized, placebo controlled trial demonstrated that Long COVID patients benefitted from sublingual use of Formula C without any safety events. This remote, observational study of Endourage Targeted Wellness Formula C™ sublingual drops will seek to empower participants to track symptoms and wellbeing while taking Formula C to determine if Long COVID symptoms are attenuated and time to healing is shortened.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 21 years of age.
2. Willing and able to read, understand, and sign the informed consent.
3. Willing to comply with all study procedures.
4. Must have device to access the internet to complete surveys online.
5. A diagnosis of Long COVID from a health care provider.

Exclusion Criteria:

1. Non-English speaking, as the surveys are developed in the English language.
2. Known allergies to hemp seeds or hemp-derived products, medical cannabis, coconut oil.
3. Pregnancy, or planning to become pregnant in the next 3 months
Effect of Dietary Sodium Restriction in the Management of Patients With Heart Failure and Diastolic Dysfunction

Although half of the patients with HF has normal ejection fraction or slightly altered (HF-PEF) and the prognosis differs little from those with reduced ejection fraction, the pathophysiology of HF-PEF is still poorly understood.

Sodium restriction is the most common measure of self-care oriented to HF patients for management of congestive episodes. The role of this orientation in the treatment of patients with preserved ejection fraction, however, is still unclear. The evaluation of the effects of sodium restriction on neurohormonal activation and episodes of decompensation in HF-PEF can promote a better understanding of the pathophysiological progression of this complex syndrome.

This is a randomized, parallel trial with blinded outcome assessment. The sample will include adult patients (aged ≥18 years) with a diagnosis of HF-PEF admitted for HF decompensation. The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800 mL/day respectively (intervention group) or an unrestricted diet, with 4 g/day sodium and unlimited fluid intake (control group), and followed for 7 days or until hospital discharge. The primary outcome shall consist of weight loss at 7 days or discharge. The secondary outcome includes assessment of clinical stability, neurohormonal activation, daily perception of thirst and readmission rate at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Age equal to or above 18 years
* Diagnosis of heart failure whit preserved ejection fraction (LVEF\> 50%)
* Patients hospitalized for heart failure decompensation whit hospital admission within 36 hours, who agree to participate in the study by signing the informed consent.

Exclusion Criteria:

* Patients who present values of endogenous creatinine clearance less than or equal to 30 ml / min;
* Cardiogenic shock,
* Those with survival compromised by another disease in evolution and / or difficulty adhering to treatment (dementia, cognitive impairment)
Affect of Dose Rate on UVR Induced Skin Erythema

Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.

Study design: A single-center, prospective, randomized, crossover, open study.

Number of patients: 20-40

Patient population: Healthy volunteers

Control: Different sites on patients body

Procedure duration: Total 3-5 hours (4 visits)

Duration of follow up: 4 days

Duration of study: Up to 6 months

Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin types I-III.
* Age 18-60.
* Absence of obvious sun damage on the volar side of the forearm or other exposure sites.
* Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment.

Exclusion Criteria:

* History of skin cancer.
* Multiple nevi or atypical nevi on the forearm.
* Signs of sun damage on the volar side of the forearm or other exposure sites.
* Mentally incompetent.
Dynamic Hyperinflation and Tiotropium

We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.

Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung

Eligibility Criteria:
Inclusion Criteria:

* Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC \< 70%.
* Smoking history \> 10 pack yr.
* Clinically stable X 6 weeks.
* No oxygen usage.

Exclusion Criteria:

* History of asthma
* Clinically unstable
* Any other significant medical problem precluding full cooperation for study
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections

The purpose of this study is to evaluate the use of a blood test: Karius® plasma-based next-generation sequencing test (Karius Test), to see if we can detect and measure the infection causing agent in children with musculoskeletal infections (MSKI).

children admitted to Riley Hospital for Children (RHC) with musculoskeletal infections (osteomyelitis, septic arthritis, or pyomyositis) over a 12-month period will be prospectively enrolled. Eligible subjects will be identified by referral from the infectious diseases and orthopedic services at RHC. Blood samples will be obtained on the day of admission (within 48hrs), and 24 hours after the admission sample for real-time NGS (next-generation sequencing) testing at Karius Laboratory (Redwood City, CA). If a pathogen is identified by NGS, in either of the first two samples, subsequent samples will be sent every 48-72 hours while inpatient, and then collected every 1-2 weeks after hospital discharge, while being treated for MSKI (maximum 3 follow-up samples). If both of the initial inpatient NGS samples are negative, no further samples will be sent for NGS. Pathogen identification by NGS will be compared to standard cultures methods, and quantitative cfDNA (cell-free DNA) will be evaluated over time.

Eligibility Criteria:
Inclusion Criteria:

1. 6 months (to ensure adequate blood volume drawn) to 18 years of age.
2. Strong clinical suspicion of MSKI as evidenced by fever, osteoarticular pain (e.g. tenderness to palpation of a joint, bone pain, or refusal to bear weight); and elevated ESR (erythrocyte sedimentation rate) or CRP (C-reactive protein).

Exclusion Criteria:

* Subjects will be excluded if they have clinical evidence suggesting an alternative diagnosis; inability or unwillingness to consent for the study
Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?

We will test on persons with chronic impairment due to stroke:

1. whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
2. whether we should train the shoulder, elbow, and wrist at the same time or on different days.

The Effect of Proximal and Distal Training on Stroke Recovery:

Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke.

Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).

Specific Aim 3. Test whether there is generalization across different joints (shoulder \& elbow vs wrist).

Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke.

Briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. A third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. Outcomes will be measured using standard instruments as well as robot-based measures. We expect that results from this study will provide an objective basis for maximizing this kind of therapy.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included in the study if they meet the following criteria:

1. naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
2. first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
3. cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
4. average Motor Power score \>= 1/5 or \<= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
5. informed written consent to participate in the study.

Exclusion Criteria:

Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
Low-Intensity Focused Ultrasound and the Complex Patient

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 18-65 years
2. Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
3. Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
4. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.
5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
6. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.

Exclusion Criteria:

1. Evidence of neuropathic pain
2. Previous spine surgery
3. Current substance use disorder other than OUD or tobacco use disorder
4. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
5. Chronic Pain Conditions other than chronic back pain
6. Daily opiate use other than buprenorphine/methadone for OUD/pain control
7. Pregnant or breastfeeding
8. History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
9. History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
10. Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
11. Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
12. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease