cyrilzakka/clinical-trials huggingface dataset:
The Effect of Nutritional Supplementation on Actinic Purpura: a Pilot Study

Purpura is a macule or papule of blood in the skin. It is mostly seen in mature skin that is often prone to significant bruising. Small lesions of less than 5 mm are called petechiae and larger ones, found mostly in subcutaneous tissue, are called ecchymosis. Actinic purpura occurs almost exclusively in elderly populations. This single-blind randomized clinical trial evaluates the effect of an 8-week nutritional supplement intervention in comparison with isolated vitamin C supplements on actinic purpura in older adults. We will enroll thirty (30) otherwise healthy participants, both male and female, aged 55 years and older. Changes in participants' skin condition will be assessed at visit 1 (baseline), visit 2 (4-week), and visit 3 (8-week) using questionnaires, standard digital photography, and clinical grading of the skin lesions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals aged ≥ 55 years old.
* Self-reported having actinic purpura lesions at the time of enrollment or a history of actinic purpura lesions.
* Self-reported not using prescription or over-the-counter products that contain aluminum, iron, proton pump inhibitors (PPIs), and/or topical retinol (used locally in areas of bruising).
* If on a chronic medication that does not result in exclusion, participant must self-report being on a stable dose for the last 3 months prior to the start of the trial.
* Able and willing to read and voluntarily sign the study Informed Consent Form (ICF).
* Able and willing to comply with study protocol and all study-related guidelines.
* Not concomitantly participating in a study involving nutritional products.

Exclusion Criteria:

* Not complying with the study protocol.
* Having a known allergy or intolerance to nuts, seeds, fruits, vegetables, oils, and fish.
* Having a known allergy, intolerance, or dietary restriction to any of the study ingredients (Vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate).
* Having a clinically significant condition that is severe, progressive, or uncontrolled and would compromise the study or their well-being or would prevent the participant from meeting or performing study requirements. This includes but is not limited to dysphagia (or difficulty swallowing), liver or kidney disease, bone marrow problems, Ehlers-Danlos syndrome, lupus, alcohol misuse, cancer, or HIV and other infections.
* Having active dermatological conditions. Patients with active, severe skin conditions that might interfere with the study's conduct or outcomes including widespread psoriasis, untreated chronic skin ulcers, or other severe dermatological disorders.
Evaluation of a Couple-Based Physical Activity Intervention

This clinical trial tests how well a couple-based physical activity (PA) intervention, Mates in Motion, works in patients undergoing hematopoietic cell transplantation (HCT) or chimeric antigen receptor T-cell therapy (CART) and their care giving partners to be more physically active. Mates in Motion provides training in communication skills and behavior change techniques to help HCT patient-caregiver dyads support one another in adoption and maintenance of PA. This study may help researchers determine if a couple-based PA intervention improves PA, physical endurance and global physical health among patient-care giver dyads undergoing HCT or CART.

PRIMARY OBJECTIVES:

I. To determine feasibility of recruitment, adherence, and retention of a couple-based PA intervention in a pilot randomized controlled trial (RCT).

II. Determine acceptability of the intervention (multiple dimensions of treatment satisfaction).

III. Describe changes in PA, physical endurance, and global physical health from baseline to follow-up as a function of randomized condition.

OUTLINE: Patient-caregiver dyads are randomized to 1 of 2 arms.

ARM I: Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.

ARM II: Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS: Age 18 years or older
* PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T cell therapy
* PATIENTS: Able to speak and comprehend English
* PATIENTS: Being married or in a committed (self-defined) cohabiting same- or opposite-sex relationship
* PATIENTS: Physician-approved for a walking program
* CAREGIVERS: Age 18 years or older
* CAREGIVERS: Able to speak and comprehend English
* CAREGIVERS: Married to or in a committed, cohabiting, same- or opposite-sex relationship with the patient
* CAREGIVERS: Able to participate in a walking program

Exclusion Criteria:

* None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered
A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin

Participants in the study are adults with CD30-positive malignancies which include classical Hodgkin lymphoma (cHL), cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF) or primarily cutaneous anaplastic large cell lymphoma (pcALCL), or systemic anaplastic large cell lymphoma (sALCL).

The main aims of the study are as follows:

* to learn about the response rates of participants with relapsed or refractory CD30+ malignancies when re-treated with BV.
* to check for side effects from re-treatment with BV.

The study will take place in approximately 30 hospitals in Spain.

The study doctors will review each participant's medical record at least 6 months after finishing the last dose of re-treatment with BV. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

This is an observational, non-interventional, retrospective study in participants with R/R CD30 positive cHL, CTCL (MF and pcALCL) and sALCL who have previously achieved a CR or PR with BV treatment and subsequently experienced disease progression were administered BV retreatment.

This study will assess the effectiveness and safety of BV retreatment in the Spanish population in real-world clinical practice. The study will enroll approximately 35 participants.

The data will be collected and recorded from the medical record of participants and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• Participants With CD30-positive Lymphoma

This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 24 months (12 months for medical chart review and 12 until publication submission).

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed cHL, CTCL (MF and pcALCL) or sALCL with CD30 positive.
2. Previously treated with BV containing regimen, with evidence of objective response (determined by having achieved CR or PR), and subsequent disease progression or relapse after discontinuing treatment BV retreatment.
3. Participants with data of disease relapse or progression greater than or equal to (\>=) 6 months since the last dose of the first treatment with BV.
4. Participant with data available at the participating site since diagnosis of cHL, CTCL (MF and pcALCL) or sALCL.
5. Having received at least, two doses of BV as retreatment and having follow up information available at the site for a minimum period of six months or until death.

Exclusion Criteria:

There are no exclusion criteria for this study.
Comparison of Quadratus Lumborum Block and Erector Spina Plane Block in Nephrectomy

Postoperative pain is important due to the limitation of physical functions, delay in recovery of quality of life, long-term opiate use, length of hospital stay, increased care costs and early postoperative pain trigger chronic pain. It is associated with postoperative morbidity. Multimodal analgesia techniques with fascial plan blocks are frequently used.The investigators aimed to evaluate the effect of QLB2 and ESP on postoperative pain scores in nephrectomy surgery, total opiate consumption, initial analgesia requirement, additional analgesia consumption, patient and surgeon satisfaction.

At the end of the operation, patients will be randomly divided into 2 groups as Group E (ESP block) and Group Q (QLB). The blocks will be administered under general anesthesia in lateral position by same anesthesiologist. Group E (ESP block) will be applied 20 ml of %0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. Group Q (QLB2 block) will be applied 20 ml of %0.25 bupivacaine at lumbar interfacial triangle (LIFT). At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, initial analgesic requirement, nausea-vomiting score, ramsey sedation scale, length of hospital stay, patient and surgeon satisfaction, and postoperative complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Partial or radical nephrectomy
* American Society of Anesthesiologist physical status I-III

Exclusion Criteria:

* Infection in the incision area
* Coagulation disorder
* Known allergy history against to the study drugs
* Lack of adequate cognitive activity in the use of patient-controlled analgesia and VAS
International Fetal Anesthesia Database

This registry aims to gather anesthetic medications administered to fetuses directly as well as those administered via the mother during fetal intervention procedures. The goal is to assesss short and medium term outcomes as well as long term outcomes of these babies whao have received medication in utero. The long term outcomes will include but are not limited to neurodevelopmental outcomes.

Advances in technology have allowed for an increase in procedures performed on the fetus in utero; these procedures involve the administration of different anesthetics (sedative- hypnotic agents and or volatile agents) to the mother and sometimes directly to the fetus in order for succesful completion of the procedure. Very few instiututions in the world perform these procedures in any significant number. The establishment of this database will serve to consolidate information regarding anesthetic drugs administered for these procedures, thereby helping to establish best practice guidelines, determine medium and short term outcomes or complications and also facilitate long term neurodevelopmental assessment of children that have undergone these procedures in utero with 5 and 10 year neurodevelopmental assessment.

Eligibility Criteria:
Inclusion Criteria: Pregnant women, fetuses and children

Exclusion Criteria: Non-pregnant women
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris

The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe acne vulgaris
* Acne vulgaris unresponsive to oral antibiotics
* Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study

Exclusion Criteria:

* Use of medications or treatments from specified pre-treatment time periods through the end of the study
* Beard, moustache, sideburns or other facial hair that may interfere with evaluation
* Other forms of acne
* History of malignancy within 5 years
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of tuberculosis
* History of chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Carvedilol on Health Outcomes in Heart Failure

The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.

Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.

Heart failure is a leading cause of death and hospitalization in the US. Designing practical approaches to improving heart failure care is therefore a national health priority. One retrospective study suggested that patients taking beta-blockers while hospitalized for heart failure had a lower risk of rehospitalization at 6-months. One prospective study suggested that starting beta blockers among hospitalized heart failure patients is safe and improves compliance. However, improved outcomes of this approach have not been prospectively demonstrated.

Comparison: Inpatient initiation of the beta-blocker carvedilol coupled with outpatient follow-up with a nurse manager was compared to usual care by internists and cardiologists.

Eligibility Criteria:
Inclusion Criteria:

* primary hospitalization with heart failure and LVEF \< 40%
* patient informed consent has been obtained
* absence of pulmonary congestion
* age \> 18 years

Exclusion Criteria:

* End-stage renal or hepatic disease
* Acute myocardial infarction as primary diagnosis during index hospitalization
* Life-expectancy \< 6-months
* Contraindication to beta blocker use
* Current beta-blocker therapy
* Planned bypass or valve surgery during index hospitalization
A Study to Evaluate the Use of an Indwelling Catheter to Obtain Cerebrospinal Fluid (CSF) by Low-rate Continuous Sampling (MK-0000-211)

This is a study to evaluate the feasibility and tolerability of low-rate continuous Cerebrospinal Fluid (CSF) sampling and to estimate the number of participants who exhibit severe baseline instability of CSF amyloid beta isoform Aß40 concentrations in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Must be in good health
* Must have a body mass index greater than or equal to 18 kg/m\^2 and less than or equal to 30 kg/m\^2

Exclusion Criteria:

* Is pregnant, nursing, or plans to become pregnant
* Has clinically significant cardiovascular, renal, hepatic, gastrointestinal (GI), neurological, endocrine, hematological, dermatological or metabolic disease, or clinically significant abnormalities, as determined by medical history, physical examination, electrocardiogram, vital signs, or laboratory tests
* Has a history of migraine headaches
* Has a history of recent lumbar CSF sampling within 3 weeks prior to screening, history of lumbar spine surgery, or chronic low back pain or injury
* Has an infection or inflammation of the skin in or in close proximity to the area of the lumbar puncture site
* Has a history of a seizure disorder
* Is noted to have papilledema or clinically significant focal neurological deficits at the screening physical examination, as well as abnormalities of CSF pressure on initial testing once access to the lumbar space is achieved
* Has absolute or relative anatomic abnormalities that would be a contraindication to lumbar puncture
* Is a heavy consumer of alcohol
* Has used nicotine in the past 6 months
* Has a history of a significant psychiatric disorder
Parker Flex-it Stylet Versus Malleable Stylet in Orotracheal Intubation Using a Fiber-optic Laryngoscope

Objectives: To compare the safety and efficacy of Parker flex-it directional stylet (PFDS) versus conventional malleable stylet (CMS) in orotracheal intubation (OTI) using fiber-optic Macintosh laryngoscope.

Background: OTI is used in general anesthesia for anesthetic delivery and ventilation of patients. OTI delay or failure may adversely affect patient outcomes, therefore, anesthetists with sufficient clinical experience and skill should perform OTI. However, in emergency situations, experienced anesthetists may not be available, and the patient may have a high Cormack-Lehane grade. A stylet is commonly used in the emergency department to aid insertion of the endotracheal tube during direct laryngoscopy.

Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 80 patients requiring OTI under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group DS, intubated using PFDS, and group MS, intubated using CMS.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 60 years
* Body Mass Index (BMI) \< 35
* Mallampati classification ≤ II

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status \> II
* Age \< 21 years or \> 60 years
* Body Mass Index (BMI) ≥ 35
* Mallampati classification \> II
* Pregnant women
* Anticipated difficult airway
* Need for rapid sequence induction
* Increased risk of gastric aspiration such as gastroesophageal reflux
* Edentulous patients, Loose teeth
* Known pathology, trauma, or previous surgery to the mouth, pharynx, larynx, or cervical spine
* History of; Dysrhythmia, Hypertension, Ischemic heart disease, Hyperthyroidism, DM
Evaluating Replacement of Standard-of-care Low Dose Computer Tomography (CT) Scans With Radiation-free Bone Imaging by Deep-learning Augmented Zero Echo Time (DL-ZTE) Magnetic Resonance Tomography (MRT)

The goal of this clinical trial is to determine how effectively bone structures of the human skeleton can be visualized using Deep Learning (DL) augmented Magnetic Resonance Imaging (MRI) in individuals with inflammatory and degenerative joint changes, compared to Computed Tomography (CT). MRI is a technique that operates without the use of X-rays. The main question it aims to answer is:

1. Can DL MRI accurately depict bone structures as well as CT?
2. Can DL MRI be used as an alternative to CT to avoid exposure to X-rays in the future?

Researchers will compare DL MRI scans to CT scans to see if DL MRI can effectively replace CT in visualizing bone structures without the use of radiation.

Participants will:

1. Undergo MRI scans of their skeletal system that will then be processed using DL.
2. Undergo CT scans of the same body region for comparison purposes.


Eligibility Criteria:
Inclusion Criteria:

* Referral for a clinically indicated MRI examination of the musculoskeletal system to assess inflammatory and degenerative joint changes.
* Willingness to sign the informed consent form.
* No contraindications for a CT examination (e.g., claustrophobia).

Exclusion Criteria:

* No signed informed consent form.
* Patients under 18 years of age.
* Pregnant women.
* The calculated effective dose of the CT examination exceeds 5 mSv.
Septal Shift for the Diagnosis of COnstrictive Pericarditis: The Impact of Inspiratory Effort Quantification on Deep Breathing Manoeuvres

This study will evaluate the effect of deep breathing manoeuvres on inter ventricular interdependency physiology. By providing further insight in this basic physiology we want to add more comprehensive data in favor or not of constrictive pericarditis diagnostic criteria currently used in cardiovascular magnetic resonance.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 80 years old
* Normal transthoracic echocardiogram if older than 41 years old
* Normal standardized history and physical examination
* Normal blood pressure (\<130/80)
* Normal 12-lead ECG at rest.

Exclusion Criteria:

* No prior pulmonary or cardiac diseases
* Unexplained symptoms that could be related to a heart or pulmonary problems.
* Symptoms of or active cardiovascular or pulmonary problems
* Hepatic or kidney dysfunction
* Blood cell dyscrasia
* Cardiovascular risk factor (smoking, hypertension, dyslipidemia, diabetes)
* Obesity (BMI \> 30)
* Pregnancy or pregnancy in the last year
* Cardiac congenital anomalies discovered during the cardiovascular magnetic resonance
* Current medication with cardiovascular side effects known (diuretics, beta-blockers, calcium channel blockers)
* Contraindication to cardiovascular magnetic resonance
A Preference Study Comparing Kristalose® and Liquid Lactulose

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recently diagnosed chronic constipation requiring treatment.

Exclusion Criteria:

* Patients with galactosemia (galactose-sensitive diet).
* Patients less than 18 years of age.
* Patients currently on lactulose therapy.
* Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions.