cyrilzakka/clinical-trials huggingface dataset:
Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life \[QoL\]), workability, and disease activity.

This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a adalimumab containing regimen has to be decided in advance and has to be current practice. The prescription of adalimumab is clearly separated from the decision to include the participant in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (AZA/6-MP); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC
* Patients who are able to complete patients questionnaires (e.g., WPAI:UC and sIBDQ questionnaire)
* Patients must fulfill national and international guidelines for the use of biologic therapies in UC (Chest X-ray and Interferon-Gamma-Release Assay (IGRA) or tuberculin purified protein derivative (PPD)-skin test negative for tuberculosis).
* Patients who have been prescribed adalimumab in line with the European SmPC (Summary of Product Characteristics)

Exclusion Criteria:

* Previous therapy with TNF-alpha (Tumor necrosis factor alpha) blocker
* No signed written authorization to use data
* Contraindication to adalimumab therapy according to the SmPC
* Patients with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or planned bowel surgery.
* Patients received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period.
* Pregnant patients
Causes and Mechanisms of Space Hemolysis At High Altitudes

Anemia is a lack of red blood cells (RBCs) in the circulation. Because RBCs carry the oxygen your body needs to function, anemia can affect one's ability to stay awake, alert, and perform physical activities. Anemia may happen for several reasons, including increased RBC destruction. Anemia often occurs in people who have been in bed for long periods (e.g., if they are very sick) or have decreased mobility (anemia of immobility). Interestingly, astronauts who have left Earth and traveled in space also return anemic. In fact, 5 decades of NASA data showed that astronauts' anemia was more severe the longer they were in space. In another study, astronauts aboard the International Space Station were shown to destroy 54% more of their RBCs in space. RBC destruction may be the culprit of space anemia as well as anemia of immobility on Earth. The ANEMIA Study proposes to measure key aspects of RBC destruction in astronauts in space. These measures will test critical hypotheses on the effects of spaceflight on red blood cells.


Eligibility Criteria:
Inclusion Criteria:

* Astronauts selected to fly on a space mission.

Exclusion Criteria:

* Astronauts not selected to fly on a space mission.
Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial

Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression.

Midodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache.

On the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.


Eligibility Criteria:
Inclusion Criteria:

1. The study will include 90 adult female patients, 45 in each group (between 18-35 years old).
2. patients of ASA physical status class I and class II.
3. patients scheduled for elective cesarean section under spinal anesthesia.

Exclusion Criteria:

1. Patient refusal.
2. Contraindication to spinal anesthesia .
3. Patients known allergic to Midodrine or Norepinephrine.
4. Patients with preexisting cardiovascular or cerebrovascular disease.
5. Patients with diabetes mellitus.
6. Patients with psychiatric disease or on psychiatric treatment.
The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD

This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms.

This pilot study looks to further the current floatation-based REST literature by exploring the therapy's effectiveness within a community-based sample of adults with PTSD. This type of sample allows the study the opportunity to recruit both veteran and civilian subjects, two populations that can suffer from this clinical diagnosis and stand to benefit from this therapy. This study will:

1. Evaluate the psychological effects of floating for a clinical, community sample with PTSD.
2. Evaluate the physiological effects of floating for a clinical, community sample with PTSD.
3. Evaluate the subjective effects of floating for a clinical, community sample with PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
* 18-60 years of age

Exclusion Criteria:

* History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
* Any skin conditions or open wounds that could cause pain when exposed to saltwater
* Has floated previously
* Has Schizophrenia spectrum or other psychotic disorders
* Refuses to adhere to the Pre-Float Checklist
* Non-English speaking
* Inability to lay comfortably in a shallow pool of water
* Refuses participation in the floatation-REST sessions
* Refuses to sign the Float Liability Waiver prior to floating
* No Communicable disease (e.g.- HIV, Hepatitis A, B\& C, tuberculosis, or measles)
* No psychoactive drugs or laxatives within the past week from scheduled float. Psychoactive drugs include, but are not limited to: methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), psilocybin, peyote, phencyclidine, ketamine).No recreational drug use (e.g.tetrahydrocannabinol,abuse of prescription medicine) day before or day of study visit. No antihistamine that causes drowsiness and no alcohol the day of the float sessions.
* Lack of control of bodily functions prior to scheduled float
* Fresh tattoos that would inhibit ability to float (consult with tattoo artist)
* Colored/dyed hair less than one week old from scheduled float
* Body tanning/spay/paint less than one week old from scheduled float
* Active suicidal ideation
Application of Megavoltage Imaging to Reduce Artifact After Seed Implants

This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.


Eligibility Criteria:
Inclusion Criteria:

Male 50-80 years of age Eligible for interstitial brachytherapy implants

Exclusion Criteria:

-
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults and adolescents (≥12 years and ≥40 kg)
* Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
* Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
* Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
* ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
* History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria:

* Prior treatment with dupilumab or tralokinumab
* Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
* Treatment with any of the following agents within 4 weeks prior to the baseline visit:

  * Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
  * Phototherapy and photochemotherapy (PUVA) for AD
* Treatment with the following prior to the baseline visit:

  * An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
  * Cell-depleting biologics, including to rituximab, within 6 months of baseline
  * Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
* Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
* Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
* Evidence of active acute or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology
* History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex

This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.

Dystonia is a movement disorder which is characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures of the trunk, neck, face, or arms and legs. In focal dystonia, the abnormal movements involve a single area of the body. A commonly described form of focal dystonia is cervical dystonia (CD). Botulinum toxin treatment can be offered as a treatment option for the treatment of CD.

The current practice for botulinum toxin injection treatment is to inject patients every 3 months. However, not all patients receive continuing benefit from botulinum toxin injections for an entire 3 months. In a recent survey, approximately 45% of patients report that they would prefer a treatment cycle of less than 10 weeks.This study will compare Xeomin®, a botulinum toxin treatment, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of CD. The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.

The purpose of this research study is to evaluate the efficacy of the Short Flex dosing of Xeomin® compared to the Long Flex dosing regimen of Xeomin®, using a standard scale completed by the doctors and subjects as well as questionnaires that ask subjects to rate symptoms of CD.

Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

Exclusion Criteria:

* Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
Cultural Competence Education Given According to the Peer Education Model

The aim of the study is to determine the effect of cultural competence education given according to the peer education model on the cultural competence levels of student nurses.

Nursing students will be given cultural competence training (with peer education model) and then the effectiveness of this training will be evaluated.

Eligibility Criteria:
Inclusion Criteria

* Not receiving training on cultural competence,
* Participated in Cultural Competence Peer Training for the experimental group,
* Filled out the survey 3 times on the specified dates for the experimental and control groups,
* Volunteer to participate in the research,
* 3rd and 4th year nursing students.

Exclusion criteria:

* Receiving training on cultural competence,
* Not participating in Cultural Competency Peer Training for the experimental group,
* Failure to fill out the survey 3 times on the specified dates for the experimental and control groups,
* Those who do not volunteer to participate in the research,
* 1st and 2nd year nursing students,
* Students who want to leave the study.
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19-80
* Patients with primary hypercholesterolemia
* Those who voluntarily written consent to participate in this clinical trial

Exclusion Criteria:

* The subject not meet the specified LDL-C level
* Other exclusions applied
Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations

The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:

* "ON" time with no dyskinesia or non-troublesome dyskinesia
* "OFF" time


Eligibility Criteria:
Inclusion Criteria:

1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
2. Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
3. On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
4. Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
5. Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
6. Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
7. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
8. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.

Exclusion Criteria:

1. Patients with atypical or drug-induced Parkinson's disease.
2. Patients with a known history of hypersensitivity to levodopa or carbidopa.
3. Patients who receive treatments with dopamine receptor blocking agents
4. Patients with a history of seizures except of childhood febrile seizure.
5. Patients with dementia.
6. Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
7. Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
8. Patients with an immune-compromised state.
9. Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
10. Patients with a calculated creatinine clearance (Clcr) \< 50 mL/min using the Cockcroft-Gault equation.
11. Patients who have a difficulty swallowing tablets.
12. Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
13. Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
Inflammatory Mediators and microRNA Analysis in Premenstrual Asthma

A small number of women with asthma have an increase in asthma symptoms during the premenstrual or menstrual period. This study is being done to investigate the possible causes of this premenstrual increase in asthma symptoms and to help asthma care providers identify those patients who may suffer from this condition.

It is well established that women suffer more asthma symptoms and worse health-related quality of life than men with the same level of asthma severity. The etiology for these sex-related differences in unknown, but a subset of women has premenstrual asthma (PMA) with worsening of their asthma symptoms either prior to or during menstruation. Previous small trials have suggested that an increase in the host inflammatory response may correlate with PMA symptoms. We have evidence that small inhibitory ribonucleic acids, microRNAs, circulating in the peripheral blood of human patients may be expressed in different patterns in certain disease states when compared to healthy individuals.

We plan to compare the patterns of microRNA expression in a well characterized group of women with PMA to those without PMA to determine if alterations in these microRNA patterns play a role in increased asthma symptoms in the premenstrual period. In addition, we plan to compare the levels of inflammatory markers in these populations to better define the specific subset of women that may be at risk for premenstrual asthma. By better characterizing these women, we hope to identify clinically relevant predictors that may guide therapy for women who suffer from PMA.

Procedures to be used in this study include questionnaire administration, pulmonary function assessment, exhaled nitric oxide evaluation, urine sampling for pregnancy, and blood draws for microRNA and serum leukotriene evaluation. These techniques are utilized widely in clinical asthma research, and are associated with minimal risk.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma

Exclusion Criteria:

* Are pregnant
* Take hormonal medication
* Have an illness with fever (\> 38.0 ˚ C or 100.4 ˚ F) within 24 hours of Visit 1 or between Visits 1 and 2
* Are participating in another interventional research trial
* Have other major chronic illnesses that would interfere with participation
* Are taking the following medications: leukotriene receptor antagonists, oral steroids, anticoagulants, or insulin
* Are unable to provide consent
Comparison Between Mini-midline and the Peripheral Intravenous Catheter

The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.

The main questions it aims to answer are:

* Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;
* Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.

Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms.

A standard peripheral intravenous catheter (PIVC) or a mini-midline (LPC) will be placed according to routine clinical indications (i.e., for blood withdrawal and IV drug therapy) in patients seeking care at the Emergency Department. On admission at the Emergency Department triage desk, patients will be assigned a triage code according to clinical assessment by the triage nurse and will be evaluated as to the probability of being eventually admitted to hospital. Following enrollment, patients will be randomly assigned to receive LPC or PIVC. The follow-up period begins after catheter placement and continues through transfer to a hospital ward. During this period of catheter management, the insertion site and dressing will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* High probability of hospital admission
* Sufficient venous patrimony according to EA-DIVA scale score

Exclusion Criteria:

* Patients already having a venous access in place
* Patients requiring life-saving treatments
* Patients seeking ambulatory care
* Patients unable to express informed consent