cyrilzakka/clinical-trials huggingface dataset:
Pregnancy Eating Attributes Study

The primary purpose of this observational cohort study is to examine the role of "food reward" in maternal diet and weight change during pregnancy and postpartum. The study will further examine the importance of food reward in the context of behavioral control and other related aspects of eating behavior, as well as weight-related biomedical, psychosocial and behavioral factors including genetics, physical activity, stress, sleep and depression. Four hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments will occur at baseline (\<12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and 28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. Measures will include assessments of food reward and related constructs, dietary intake, other health behaviors, and anthropometrics. Clinical data and biological specimens will be obtained. Infant anthropometrics and feeding practices will also be assessed. Primary exposures include aspects of food reward and behavioral control, which will be assessed in multiple ways to maximize information and utility. Primary outcomes include gestational weight gain, postpartum weight retention and dietary quality.


Eligibility Criteria:
Inclusion Criteria:

* Female confirmed pregnant \<12 weeks at screening
* Uncomplicated singleton pregnancy anticipated
* Age \>=18 and \<45 at screening
* Willingness to undergo study procedures and provide informed consent for her participation and assent for the baby's participation
* BMI \>=18.5 (to qualify as normal: 18.5-24.9; overweight 25-29.9; or obese : \>=30)
* Able to complete self-reported assessments in English
* Access to Internet with email to complete self-reported assessments
* Plan to deliver at UNC Hospital
* Plan to remain in the area for 1 year following delivery

Exclusion Criteria:

* Pre-existing diabetes (type 1 or type 2)
* Multiple pregnancy
* Participant-reported eating disorder
* Any fetal anomaly requiring surgery with hospital admission following delivery (e.g. NTDs, gastroschisis, cardiac defects, Trisomy 21)
* Any medical condition contraindicating participation in the study such as chronic illnesses or use of medication that could affect diet or weight e.g. cancer, HIV, active renal disease, MI in the last 6 months, chronic steroid use, thyroid disease requiring medication, or autoimmune disease (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome, scleroderma)
* Psychosocial condition contraindicating participation in the study such as bipolar, schizophrenia, major affective disorder, substance abuse.
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants \<121 days of age and \< 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) \>48 hours of age and ≤28 days and 2) \>28 days of age and \<121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.


Eligibility Criteria:
Inclusion Criteria:

* \< 28 weeks gestation at birth
* \> 48 hours and \<121 days of age at the time of study drug administration
* One of the following:

  * Suspected systemic infection
  * Receiving cefazolin for prophylaxis
  * Receiving cefazolin treatment of a systemic infection

Exclusion Criteria:

* History of anaphylaxis attributed to a β-lactam
* Exposure to cefazolin in the month prior to study
* Serum creatinine \> 1.7 mg/dL
Engineered Dendritic Cell Vaccines for Multiple Myeloma

The purpose of this study is to determine the feasibility, safety, and efficacy of dendritic cell (DC) vaccines in the treatment of multiple myeloma (MM) or plasmacytoma based on immune-modified DC vaccines (DCvac). This approach is aimed to achieve prolonged maintenance of remission in multiple myeloma or plasmacytoma patients.

Multiple myeloma (MM) is a plasma cell malignancy, characterized by the aberrant occupation of bone marrow with malignant plasma cells, and the destruction of bones together with the production of abnormal immunoglobulins. The clinical symptoms and signs can be manifested through various mechanisms. At present, the therapeutic drugs for MM include glucocorticoid, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies including hematopoietic stem cell transplantation (HSCT). Among them, immunotherapy has been proven to be a revolutionary treatment with great potential of producing long term cure.

In the past decades, adoptively transferred T cells modified with chimeric antigen receptors (CARs) have demonstrated high effectiveness, and the CAR-T therapy has changed the treatment paradigm for many hematological malignancies. Currently, several antibody-based therapies and a few BCMA-based CAR-T cell therapies have been approved for MM treatment. However, in many MM patients, the disease may still relapse after extensive immunotherapies including auto- and allo-HSCT. We have previously reported a DC-based immune activation strategy against MM in a preclinical study. This study proposes to apply the individual patients' MM tumor antigen-based DCs as vaccines (DCvac) to booster anti-myeloma immunity, in order to prevent disease relapse. The MM patients who have achieved very good partial or complete remission will be treated with multiple DCvacs to achieve a prolonged remission without disease recurrence.

This trial protocol will inject DCvacs to MM or plasmacytoma patients who have been treated with a combination of anti-cancer regimens, including CAR-T cell therapy, and who have achieved partial or complete disease remission. The DCvacs are patient's own DCs which are immune modified to present target antigens and to activate anti-cancer immunity. The aim of this study is to evaluate the feasibility, safety, and efficacy of the innovative MM patient-based DC vaccines.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with multiple myeloma or plasmacytoma
* Very good partial or complete remission (CR) after prior combination therapies.
* Expected survival \> 12 weeks
* Adequate venous access for blood withdrawal or apheresis, and no other contraindications for blood withdrawal
* Voluntary informed consent is given with willingness to continue follow up

Exclusion Criteria:

* Pregnant or lactating women
* Uncontrolled active infection
* HIV or active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids; the use of inhaled steroids is not exclusionary
Automated Telephone Reminder for Colonoscopy

This is a quality improvement study to determine the impact of an automated telephone reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.

Randomized trial of automated reminders with bowel prep instructions and encouraging clear fluid ingestion. The phone calls will occur 48-96 hours prior to the scheduled colonoscopy.

All patients undergoing outpatient colonoscopy and prescribed sodium picosulfate plus magnesium citrate will be eligible for enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Scheduled for outpatient colonoscopy at a later date
* Prescribed evening-before or split-dose low volume preparation regimens

Exclusion Criteria:

* Refusal to receive automated telephone reminder
* No access to telephone
* Urgent/emergent indication for colonoscopy
* Prescribed a bowel prep other than Pico-Salax/Purgodan
* Receiving upper and lower combined procedure
A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece

This study estimates the treatment goal achievement rate, depicts the implementation of the Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in Greece.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) \>10 or PASI \>10 and DLQI \>10
* Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
* Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
* Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
* Patients with a signed informed consent document

Exclusion Criteria:

* Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
* Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
* Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
* Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
* Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.
Prednisolone vs. Ciclosporine in Severe Atopic Eczema

To investigate the comparative efficacy of Ciclosporine A and Prednisolone in adult patients with severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients age \>= 18 and \< 55
* weight between 50 and 100 kg
* confirmed diagnosis of AE (UK working party criteria)
* objective SCORAD \> 40
* DLQI \> 10
* resistancy against topical treatment options including steroids and calcineurin-inhibitors

Exclusion Criteria:

* participation to another clinical trial within the last 4 weeks before baseline
* pregnant or breastfeeding
* women of childbearing potential without adequate contraception
* allergy against prednisolone or Ciclosporine A
* acute bacterial or viral infection
* malignant tumor in personal history
* diabetes mellitus
* arterial hypertension
* Glaucoma
* peptic ulcer
* severe osteoporosis
* tuberculosis in personal history
* colitis ulcerosa
* diverticulitis
* concurrent treatment with chloroquin, Mefloquin, Statins, Warafin
* Creatinin Clearance \< 60 ml /min
* UV treatment within 8 weeks before inclusion
* ongoing systemic immunosuppressive treatment
* planned vaccination within 8 weeks before study entry, during study and 2 weeks after end of study
* Poliomyelitis
* Lymphadenitis after BCG vaccination
* Hyperuricaemia
* chronic liver disease
* Xeroderma pigmentosum, Cockaye-Syndrome, Bloom Syndrome
* Psychiatric co-morbidity
* drug or alcohol abuse
The Effects of Mirror Therapy on Upper Extremity in Stroke Patients

The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.

55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost. MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere. However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed. In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT might augment the cortical reorganization. In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.

Eligibility Criteria:
Inclusion Criteria:

* The onset duration more than 3 months
* Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
* No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
* No serious visual and visual-perception impairments
* No concurrent participation in other drug or rehabilitation research
* No serious attention deficits
* No excessive spasticity in any of the joints of the affected UL exclusion criteria

Exclusion Criteria:

* Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
* Excessive pain in any joint that might limit participation
Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.

The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.

The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022.

Data from five visits will be collected:

* Baseline preoperative (maximum 90 days prior to surgery)- retrospective
* IOL implantation Day 0 - retrospective
* Postoperative visit at Day 1 (+/- 0 days) - retrospective
* Postoperative visit at 1 month (+/- 2 weeks) - retrospective
* Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females above 18 years of age;
* Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 2022);
* Diagnosis of cataract and/or ametropia (hyperopia, myopia);
* Subject who has signed an informed consent form.
* Patients who have participated in all visits that are subject to retrospective data collection.

Exclusion Criteria:

* - Patients who are not targeted to emmetropia.
* Patients with the following condition(s) at the time of the baseline visit:

  * Corneal astigmatism \> 1.0 diopter
  * Uncontrolled diabetic retinopathy
  * Iris neovascularization
  * Congenital eye abnormality
  * Uncontrolled glaucoma
  * Pseudoexfoliation syndrome
  * Amblyopia
  * Uveitis
  * AMD (advanced AMD)
  * Retinal detachment
  * Prior ocular surgery in personal medical history
  * Previous laser treatment
  * Corneal diseases
  * Severe retinal diseases (dystrophy, degeneration)
  * High myopia
  * Inadequate visualization of the fundus on preoperative examination
  * Patients deemed by the clinical investigator because of any systemic disease
  * Pregnancy
  * Eye trauma in medical history
  * Current use of systemic steroids or topical ocular medication
* Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early Mild Symptoms of COVID-19

Quercetin is a flavonoid dietary supplement that occurs in many edible fruits and vegetables. It has remarkable antioxidant, anti-inflammatory, immunoprotective and antiviral properties. It is widely used to boost the body immune system against infections and keeping healthy life-style. The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and symptoms improvement in the early stage of infection.

The strong antioxidant and anti-inflammatory properties of quercetin are closely related to its effective fight against a variety of disease conditions related to inflammation, including: viral infections, allergies, asthma, hay fever, arthritis, respiratory diseases, "hardening of the arteries" (atherosclerosis), high cholesterol, heart disease and circulation problems, insulin resistance and diabetes, eye-related disorders, including cataracts, stomach ulcers, cognitive impairment, gout, cancer, chronic fatigue syndrome, inflammation of the prostate, bladder, and ovaries, chronic infections of the prostate, skin disorders, including dermatitis and hives. Quercetin can help stop damaging particles in the body known as free radicals, which damages the cells by natural oxidation processes. It can also reduce the expression of inflammatory genes in the cells.

Quercetin has been shown to be effective against broad range of viruses including human respiratory syncytial virus (hRSV), rhinovirus, echovirus, coxsackievirus, poliovirus, parainfluenza type 3, Herpes Simplex Virus-1, cytomegalovirus, SARS-CoV-1, dengue virus, and Hepatitis C virus.

The purpose of the present study is to investigate the potential benefits of quercetin for preventing COVID-19 disease progression and improving symptoms in the early stage of infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older, of either gender
* Patients must be tested positive for SARS-CoV-2 by RT-PCR
* Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
* Patients must be in the early stage of COVID-19 disease who do not require hospitalisation at the time of screening
* Patients must be under the care of a Physician for diagnosis of COVID-19
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with proven hypersensitivity or allergic reaction to quercetin
* Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis
* Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
* Patients with moderate or severe thrombocytopenia (platelet count \<100 × 10⁹/L);
* Pregnant patients
* Patients declining to participate
Analysis of Donor Biopsy Tissue Samples at the Time of Kidney Transplant

The purpose of this study is to see if substances measured in a small piece of the donor organ predicts how well the organ will function in the recipient after transplant. We will be testing blood, urine, and biopsy tissue samples in this study. The research team will be looking at different risk factors in the donor organ that predict how well the kidney will do in the recipient.

Background:

Early post-transplant kidney function can be attributed to inherent donor characteristics, damage from storage, and perioperative events and recipients factors. The incidence of severe injury to the transplant kidneys is 10-25% in the early post-transplant period. In addition, milder forms of early transplant kidney injury can impact on long term allograft function. Severe transplant kidney injury in the immediate post-transplant period has been hypothesized to be associated with higher rates of rejection.

Hypothesis:

In the current investigation, we would like to test the hypotheses that 1) mRNA and microRNA expression of proinflammatory genes in donor tissues is a risk factor for development of early kidney transplant dysfunction and 2) early inflammatory mRNA and microRNA expression in the allograft is associated with subsequent activation of cell mediated immunity as evidenced by increased incidence of acute rejection episodes and increased expression of cell mediated immunity genes during the first year post-transplant.

Aims:

Aim 1: Test the association between proinflammatory mRNA and microRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation.

Aim 2: Test the association of mRNA and microRNA expression of proinflammatory mediators in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \<80 years of age for kidney
* Recipients of single abdominal organ transplant
* Ability to provide written informed consent
* Donor blood and kidney biopsy tissues specimens are collected at the time of transplantation

Exclusion Criteria:

* Need for combined organ transplantation.
* Inability or unwillingness of a participant or legal guardian to provide written informed consent
* Clinical evidence of systemic bacterial infection in the recipient at the time of transplantation
IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

The ideal blood pressure management strategy during endovascular therapy (EVT) for acute ischemic stroke has not been defined. The aim of this pilot randomized clinical trial is to determine whether randomization to a standard versus individual blood pressure management strategy during the EVT procedure is feasible.

Acute ischemic stroke (AIS) is a leading cause of death and long-term disability in the Western world. Catheter-based removal of blood clots (endovascular therapy-EVT) is now the standard of care for AIS caused by large vessel occlusions in the brain. The level of blood pressure during the procedure appears to influence outcome. However, optimal blood pressure management strategy has not been determined. Current blood pressure management strategy during EVT typically aims to maintain blood pressure above or within predefined fixed targets and is based on observational data and expert consensus rather than on high-quality randomized evidence. Should blood pressure during removal of the occlusion be managed according to the patient's individual blood pressure level or according to predefined fixed blood pressure targets? The primary aim of this pilot trial is to determine whether randomization to a procedure strategy targeting a predefined mean arterial blood pressure (MABP) of 70-90 mmHg versus an individual strategy targeting ± 10 % of a MABP reference value is feasible. Secondary aims are to test recruitability and to detect challenges or obstacles that would call for changes in the study design.

Eligibility Criteria:
Inclusion Criteria:

* Large vessel occlusion in anterior circulation in patients deemed treatable with EVT.
* Living independently (mRS \< 2) before stroke.
* EVT procedure feasible within 24 hours of symptom onset.

Exclusion Criteria:

* Contra-indication/allergy to contrast agents, vasopressor agents or anaesthetics.
* Pregnancy.
* Medical condition where blood pressure targeting will be problematic (aorta dissection, etc).
* Participation in another trial.