cyrilzakka/clinical-trials huggingface dataset:
Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults

Retrospective clinical-epidemiological study aimed at characterizing COVID-19 disease in adults older than 70 years, hospitalized in the "Perpetuo Socorro" Hospital of Albacete (Spain) from 09/03/2020 until 20/04/2020. Secondary objectives will be to analyze clinical-epidemiological characteristics of COVID-19 patients treated with Baricitinib or Anakinra, and to describe the efficacy and secondary effects of those drugs.

Design: Retrospective postauthorization study. Registry study. Setting: COVID Unit, "Perpetuo Socorro" Hospital of Albacete (Spain). Participants: Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020. All patients will be included without exclussion criteria.

Measurements:

* Age, sex, residency.
* Functional assessment: Barthel index, Katz index, Functional Ambulation Classification.
* Cognitive assessment: Reisberg´s Global Deteriorating Scale.
* Comorbidity: Charlson index, disease count.
* Chronic medicines consumed.
* Disease related symptoms.
* Lab determinations: White cells, neutrophyl count, lymphocyte count, platelets, haemoglobin, INR, fibrinogen, D-Dimer, Ferritin, CRP, IL-6, urea, creatinin, AST, ALT, CK.
* Thorax X-ray findings: COVID affectation, severity, pleural effusion, heart failure signs, pneumothorax.
* Drugs used during hospitalization, number of days of treatment and total doses: Anakinra, Baricitinib, Glucocorticoids, Antivirals (Lopinavir/Ritonavir, Emtricitabina/Tenofovir), Azitromycin, Ceftriaxone, Hidroxychloroquin.
* Geriatric syndroms: Delirium, immobility, dysphagia, pressure ulcers.
* Outcomes: Mortality at discharge, institucionalización at discharge, length of stay, change in lab results, change in X-ray results, change in function at discharge.

Registry procedures: Medical chart review by trained Geriatricians, pharmachological chart review by expert Pharmacists, X-ray review by trained radiologists. All data will be included in an anonimyzed database for further analysis by investigators, and supervised by Principal Investigator.

Regulatory status: The protocol was approved by the Ethics review committee of Albacete (number 2020-21 from 20/04/2020) and by the Spanish Medicines Agency (AEMPS) who gave a "Postauthorization Study" classification (number PAS-BAR-2020-04. 20/04/2020).

Analysis: Two stage analysis will be conducted. In first one, efficacy and security analysis of the 99 patients that have received either Baricitinib or Anakinra will be conducted, and in the second one, clinical-epidemiological analysis of the complete sample, n=576, will be realized.

Eligibility Criteria:
Inclusion Criteria:

* Adults older than 70 years hospitalized for COVID-19 disease between 09/03/2020 and 20/04/2020, in the "Perpetuo Socorro" Hospital of Albacete (Spain).

Exclusion Criteria:

* None
To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male of female aged 20 years or more
* History of reflux esophagitis
* Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
* Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.

Exclusion Criteria:

* Use of other PPIs and/or H2RA during rabeprazole treatment
* History or having other gastrointestinal diseases
* History of upper gastrointestinal surgery
* Initiation of medications that can affect digestive functions within 4 weeks before study treatment
* Inability to complete questionnaires
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors

Exercise training has beneficial effects in cancer survivors to minimize some of the side effects of cancer and its treatment and improve long-term prognosis, but there are numerous hurdles for individuals diagnosed with, and being treated for, cancer to participate in exercise programs. The goal of this research study is to begin to evaluate whether exercise training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal muscle size and function in cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. stage I, II or III breast cancer
2. receiving neoadjuvant or adjuvant chemotherapy with or without radiation
3. a body mass index \<35 kg/m2.

Exclusion Criteria:

1. metastatic disease, a prior history of cancer, excluding non-melanoma skin cancer, or prior receipt of chemotherapy
2. autoimmune, vascular or neuromuscular disease that could alter skeletal muscle
3. prior knee or hip replacement
4. contraindications for use of neuromuscular electrical stimulation, including an implanted cardiac defibrillator or pacemaker, lower extremity blood clot or coagulopathy
5. pregnancy
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors

This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
* At least 18 years of age
* Measurable or evaluable disease
* Adequate organ function as defined per protocol

Exclusion Criteria:

* Symptomatic or unstable brain metastases
* Pregnancy or lactation
* Other protocol specified criteria
18F-Fluciclovine PET-MRI in High-grade Glioma

The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.

Following radiation and immunotherapy, many pediatric participants with high-grade gliomas (HGG), including diffuse midline glioma (DMG), demonstrate radiographic findings suspicious of disease progression. Differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. Unfortunately, conventional MRI cannot reliably distinguish between true progression and post-treatment changes. Therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical.

The overall objective of this current application is to evaluate 18F-fluciclovine PET imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric HGG. The long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric HGG using 18F-fluciclovine PET imaging.

Eligibility Criteria:
Inclusion Criteria

* 1. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating \&gt;=2/3 of the pons).
* 2. Measurable disease, measuring at least 1x1 cm.
* 3. Life expectancy of greater than 8 weeks.
* 4. Age \&gt; 1 years but \&lt; 21 years of age at enrollment.

For those without planned surgery:

* 1. Participants with clinical and/or radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan.

or

* 2. Participants with suspicion for TP or PsP on first post-radiation MRI

For those with planned surgery:

* 1. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.

Exclusion Criteria:

* 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
* 2. Pregnant or breastfeeding participants.
* 3. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).
* 4. Participants who weigh less than 8 kg.
* 5. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.
* 6. Participants with a history of abnormal kidney function or creatinine \&gt;= CTCAE v5.0 grade 2 at time of study registration.

  7. Participants with primary tumors of the spinal cord.
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique

This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.

The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.

The main objective will be to evaluate the postoperative pain by BPI questionnaire.

The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.

describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy.

evaluate the postoperative pain by Brief Pain Inventory (BPI) self assesment observe the functional results of the homolateral upper limb by Disabilities of the Arm, Shoulder and Hand (DASH) self assesment observe quality of life by BREAST Q questionary

Eligibility Criteria:
Inclusion Criteria:

1. Major patients
2. With breast cancer and indication for total mastectomy
3. With a desire for immediate breast reconstruction
4. Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis
5. Information of the patient and collection of his/her non-opposition
6. Affiliation with a social securitý scheme, or beneficiary of such a scheme

Exclusion Criteria:

1. Prophylactic mastectomies
2. Metastatic patients
3. Patients requiring another surgical technique
4. Person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent,
5. Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
6. Pregnant or likely to be pregnant
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* mantle cell lymphoma
* Initial immunophenotyping with CD20 and CD5.
* CD20+.
* t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
* Patient no previous treated.
* At least one tumor site accessible for assessment
* Aged \> 18 years \< 65
* ECOG \< or = 2.
* No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
* signed informed consent
* FEVG 50%

Exclusion Criteria:

* other type of lymphoma
* ECOG \> or = 3
* relapse
* serology VIH + Hepatite +
* diabetis
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine

This will be an Investigator-initiated pilot study in which participants will be assessed with various scales to measure demoralization, anxiety, depression, and subjective incompetence at baseline and every two weeks after treatment with Valbenazine for a total of 6 weeks. Improvement in TD will be assessed as well and correlated with reduction in demoralization.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 26-84
2. Sex: Both males and females will be included
3. Diagnosis of dopamine receptor-blocker induced tardive dyskinesia according to the DSM-5 criteria: "involuntary athetoid or choreiform movements lasting at least a few weeks, developing in association with the use of a neuroleptic medication for at least a few months, and persisting beyond 4-8 weeks"

Exclusion Criteria:

The following classes of patients will be excluded:

1. Patients with unstable psychiatric status defined as having a total score on BPRS of 50 or higher
2. Patients who have suicidal or homicidal ideation, intent, or plan or viewed as having a significant risk of suicidal or violent behavior;
3. Patients with cognitive impairment as defined by a score of 24 or less on the MMSE
4. Patients with current diagnosis of alcohol or substance use disorder made according to DSM-5 criteria
5. Patients with clinically significant unstable medical condition defined as follows: a comorbid abnormal movement disorder more prominent than tardive dyskinesia (e.g., parkinsonism, akathisia, truncal dystonia), a score of greater than 2 on two or more items of the Simpson-Angus Scale, or a history of neuroleptic malignant syndrome.
6. Patients previously treated with Valbenazine or any other medication specifically indicated for tardive dyskinesia
7. Patients currently taking strong CYP3A4 inducers, dopamine agonists, MAO inhibitors, stimulants, and/or VMAT2 inhibitors
8. Patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval
9. Patients with risk factors for prolonged QT such as electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia), anorexia nervosa, diuretic use, certain heart conditions, and other medical conditions
10. Patients tested positive for Coronavirus Covid-19
11. Patients with impaired decision-making capacity
12. Institutionalized individuals
13. Prisoners
Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy, female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco-using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug (augmented betamethasone dipropionate) Cream 0.05%
* Weight within + or - 20% from normal for height and weight for body frame
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating
Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study

Quality of recovery is an important outcome measure in anaesthesia, whilst there are validated tools for this in surgery and regional anesthesia there are no fully validated tools for obstetrics anaesthesia. The aim of this study is to use the Obstetric Quality of Recovery (ObsQoR) score across multiple centres to assess correlation to length of stay and variation for different types of operative and non- operative delivery.

An observational survey based study, for 3 consecutive week days, chosen by the local investigating team during a two-week period across multiple centres.

* Local investigators will complete the survey with each patient who has received anaesthetic intervention from an anaesthetist, 1 day, around 24hrs after delivery in line with their routine anaesthetic follow up.
* At 30 days, a telephone survey will be conducted with each patient to repeat the ObsQoR survey and ask key questions regarding functional recovery and activities of daily living post delivery.

In addition for a small number of sites, elective caesarean delivery patients will have blood taken at the point of anaesthesia and 24 hours post delivery to assess the immune function and any changes which may predict poorer outcome in these women.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients over 18 years old.
* Intervention occurring after 32/40 gestation.
* All mothers receiving anaesthesia or anaesthetic analgesia during their peripartum period.

Exclusion Criteria:

* Unable to comprehend the questions asked
* Patient refusal
* Under 32/40 weeks gestation
* Cervical cerclage insertion or removal, anaesthesia for External Cephalic Verison
* Neonatal death
* Non- NHS patients
Nasal Irrigation in Infants With Bronchiolitis.

Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.

Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.

The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.


Eligibility Criteria:
Inclusion Criteria:

* infants \<1 year
* diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
* oxygen saturation between 88 and 94%

Exclusion Criteria:

* previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
* chronic illness
Managing Outpatient Hysteroscopy-associated Pain

Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.

A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility

Exclusion Criteria:

* allergies to medications
* refusal to consent to the procedure or participation in the study
F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD)

The purpose of this research study is to evaluate tau distribution in the brain of subjects with: FTD caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic FTD, normal controls.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants, at least 18 years of age.
2. Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation known to cause FTD (with or without symptoms); or a normal control.
3. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
4. Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of T807 drug administration.

Exclusion Criteria:

1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a history of Torsades de Pointes or is taking medications known to prolong QT interval. To determine who will be excluded from this study based on this criterion, we will review participant's medical history and current medications at time of screening. Participants will be excluded from the study if any of the following restricted medications are being taken:

   * Disopyramide
   * Dofetilide
   * Ibutilide
   * Procainamide
   * Quinidine
   * Sotalol
   * Bepridil
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.
8. For those electing to undergo the optional lumbar puncture: on

anticoagulant of any form prior to lumbar puncture.
A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.

Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.

Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.

Eligibility Criteria:
Inclusion Criteria:

* Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
* Able to participate for four weeks.

Exclusion Criteria:

* Needing convexity.