cyrilzakka/clinical-trials huggingface dataset:
Analysis of Non-invasive Ventilatory Support Modes: High Flow Nasal Cannula and Non-invasive Ventilation

This study compares two types of noninvasive treatments for asthma attacks with the objective of analyzing the efficacy of each therapy during the period of exacerbations in infants and asthmatics hospitalized.

A randomized clinical trial, where it will be established, treatment in hospitalized asthma patients in the infirmary and Emergency Room of the Hospital Infantil Cândido Fontoura.

The children eligible for the Protocol, after signing the terms of consent and assent, will be randomized for treatment in 2 groups (GI - bilevel and GII - High Flow Nasal Cannula). After the evaluations are started: Feb1, Volume expired in the first second; Peak Flow, vital signs and calculated Pulmonary Asthma Score, Pulmonary Asthma Severity Score, Pulmonary Index Score, and therapy application. The N to be considered for the study of 20 individuals per group. Group therapy I will be applied in diaphragmatic re-education exercises 3 x 10 breaths, after non-invasive ventilation, with parameters 12 cm H2O Ipap and Epap 8 cm H2O, for 45 minutes, according to patient tolerance, interface, with full face mask After treatment, reassessment of vital signs and measurements of Peak Flow, Fev1 and Severity Scores.

The GII will be established therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight and respiratory rate at the time of evaluation, ranging from 2 l / min to 30 l / min. flow. The therapy will begin with diaphragmatic exercises 3 x 10 breaths, after 45 minutes of the installation of the therapy that is continuous, will be performed a reassessment of vital signs and Peak Flow, Feb, Severity Scores.

During the hospitalization time of the child will be carried out the daily treatment, therapy chosen for each patient for 45 minutes in the case of GI and the GII group daily follow-up and adjustment of flow dosage, also evaluated the vital signs, vital signs and Peak Flow, Feb, Gravity Scores.

At the time of hospital discharge, the evaluations will be performed and data such as inhaled corticosteroid use, oxygen use in days and inspired fraction, hospitalization days, hospital costs, as well as vital signs, vital signs and Peak Flow, Fev, Scores of Gravity.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 16 years;
* both genders;
* Be in the presence of the bronchospasm crisis;
* Be admitted to HICF Hospital;
* Have signed the search terms

Exclusion Criteria:

* Having associated heart disease;
* neurological/cognitive impairment;
* Have severe respiratory insufficiency detected by severity scores;
* Intolerance to any type of treatment
A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder

Thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE.

Participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. Participants will also be asked to complete self-report measures before and after each session. The primary aims of this study are as follows.

Aim 1: To adapt the in-person MORE intervention for telehealth delivery. Aim 2: To assess the overall feasibility and acceptability of this telehealth intervention. Hypothesis: MORE delivered via telehealth will be both feasible and acceptable to participants.

Eligibility Criteria:
Inclusion Criteria:

* Must be pregnant.
* Must be able to communicate in English.
* Must have met criteria for opioid use disorder in the past year.

Exclusion Criteria:

* None.
Arthroscopic Resection Arthroplasty of Carpometacarpal and/or Pantrapezial Osteoarthritis

Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT

The purposes of this study were to report 1) long-term outcomes on a large series of patients that underwent arthroscopic resection arthroplasty (ARA) for thumb basal joint arthritis (BJA) and 2) to compare outcomes of ARA for isolated carpometacarpal osteoarthritis versus those undergoing simultaneous ARA of CMC plus the scaphotrapeziotrapezoid joint for pantrapezial disease.

Please note, all patients treated by Dr. Cobb for CMC and/or STT OA received the same treatment regardless of whether or not they chose to participate in the study. Patients who chose to enroll in the study received the same treatment as those who did not only their data was analyzed. Data collection is the same for those who do not participate, only their data is not analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Primary cases of ARA for thumb BJA with isolated CMC ARA or simultaneous ARA of the CMC and STT joints.

Exclusion Criteria:

* Exclusions included 19 cases that received interposition materials that since have been shown to produce unfavorable postoperative inflammatory responses, (Orthadapt Bioimplant, Pegasus Biologics, Irvine, CA and Artimplant Artelon CMC-I Spacer, Small Bone Innovations, LLC, New York, NY), 6 cases that had prior CMC surgery, and 27 cases that underwent concomitant surgeries that would potentially effect outcome.
Covid-19 and Vitamin D in Nursing-home

First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological observational data are necessary for better understanding the links between vitamin D supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of hypovitaminosis D is very high).

The investigators had the opportunity to use information collected in a French middle-sized nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3 supplementation was associated with the prognosis of COVID-19 in residents infected with SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on residents).

The main objective of this study is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in improving survival among frail elderly nursing-home residents infected with COVID-19 compared to those having received supplementation longer ago.

The secondary objective is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in limiting the clinical severity of the infection according to the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 compared to those having received supplementation longer ago.

Retrospective observational unicentric study in nursing-home residents with COVID-19. Health status monitoring data available until May 15, 2020. For all participants, gender, age, disability, history and comorbidities, treatments, date of last vitamin D3 supplementation, results of last blood test, date of suspicion / diagnosis of COVID-19, COVID-19 OSCI score, and eventual hospitalization or death (surveillance data available until May 15, 2020) are collected.

Eligibility Criteria:
Inclusion Criteria:

* Living in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19 epidemic (March-April 2020)
* Being suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)

Exclusion Criteria:

- Opposition of the resident and/or relatives to the use of anonymized clinical-biological data
COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients (COST ACTION)

The aims of this study is to define the genetic bases of COVID-19 related disease heterogeneity in frail population, to carry out a retrospective study on individuals w/wo symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis and on the presence of genetic profiling and to explore the therapeutic potential of the modulation of ACE2 expression.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\> 18 years old)

Exclusion Criteria:

* inability to understand and want;
* mentally incapacitated.
Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased cells. The study will be conducted in children (2-17years old) being transplanted with stem cells from a donor. Patients undergoing stem cell transplantation are more likely to develop infections as their immune systems are weakened. Blood, stool, urine and throat swab samples will be collected (for at least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. Subjects will participate for up to 1 year following the transplant procedure.

This study is a multi-center observational study to determine the usefulness of real time PCR in the detection of adenovirus and fungal infections in patients following HSCT. Quantitative viral load monitoring will be evaluated to establish correlation with clinical symptoms and to measure the effectiveness of the therapeutic interventions. Samples will be collected prior to HSCT and on a scheduled weekly basis for 100 days post-HSCT and after that when patients show signs of infection. Patients' signs and symptoms and outcomes will be recorded for correlation with viral load. In addition, viral cultures will be performed on the same schedule as PCR assay using 3 samples (throat swab, stool, and urine). The study will be conducted at approximately 6 centers in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients greater than or equal to 2 years of age.
2. Allogeneic HSCT.
3. Willing and able to give signed informed consent, or have a legally authorized representative who is willing to give consent. Informed assent will be required for children \<18 years of age.
4. Reliable and willing to make themselves available for the duration of the study.

Exclusion Criteria:

1. Autologous transplant patients are not eligible for the study.
2. Patients previously enrolled in the study may not reenroll in the event of a subsequent HSCT.
3. Pediatric patients less than 2 years of age are not eligible for the study.
EAMA Sarcopenia in Acute Care Patients in 9+European Countries

This collaborative study in 9 geriatrics units across Europe aims to apply emerging research to clinical practice, following the "Action-Research Philosophy" (11). The overall goal is to improve care in patients with - and help prevent - sarcopenia. Understanding the frequency of and risk factors for developing sarcopenia in an acute hospital setting, may help shed light on potential interventions and thus inform the development of future therapeutic strategies. It involves crucial implications for research, clinical practice, and policy towards optimal aging.

Background: Sarcopenia is a nutrition-related disease leading to physical impairment and adverse clinical outcomes. Data regarding its characteristics in hospitalized patients are limited.

Aim: This study will assess in older patients admitted to acute medical wards, the prevalence, incidence, and risk factors for development of sarcopenia, or alteration in its severity, and evaluate associated clinical adverse outcomes.

Methods: This collaboratively-designed, longitudinal prospective observational study will be carried out in patients aged \>70 admitted to acute geriatric units in 9 European centers. The new sarcopenia diagnostic criteria of the European Working Group on Sarcopenia 2 (EWGSOP2) will be tested at admission and discharge, using isometric handgrip dynamometry, gait speed, and, pragmatically, calf circumference. There will be 3- and 12-month telephone follow-up (including the SARC-F questionnaire).

Discussion: Our study will be the first collaboration to assess the prevalence and incidence of sarcopenia (EWGSOP2) and its risk factors in hospitalized patients across Europe.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>70 admitted to acute hospital medical units

Exclusion Criteria:

* Length of hospital stay anticipated to be \<24 hours
* Hip/lower limb fractures
* Major amputations of the lower leg
* Terminally ill patients admitted for palliative care
Treatment of Benign Thyroid Nodules With FastScan HIFU

This study evaluates the efficacy of the HIFU for the treatment of benign thyroid nodules with the FastScan version using assessment of patient experience and adverse event reporting.

Echopulse is specially designed, manufactured and CE marked for treating benign thyroid nodules. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 1 site (Bulgaria), 20 benign thyroid nodules were treated. The HIFU treatment was well tolerated and showed efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient 18 years or older.
* Patient presenting with at least one thyroid nodule with no signs of malignancy:

  1. Non suspect clinically and at ultrasonography imaging
  2. Benign cytological diagnosis at FNAB (fine-needle aspiration biopsy) from the last 6 months
  3. Normal serum calcitonin
  4. No history of neck irradiation
* Normal TSH (thyroid-stimulating hormone)
* Targeted nodule accessible and eligible to HIFU
* Absence of abnormal vocal cord mobility at laryngoscopy
* Nodule diameter ≥ 10mm measured by ultrasound
* Composition of the targeted nodule(s) : predominantly solid
* Patient has signed a written informed consent.

Exclusion Criteria:

* Head and/or neck disease that prevents hyperextension of neck
* Known history of thyroid cancer or other neoplasias in the neck region
* History of neck irradiation
* Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
* Posterior position of the nodule if the thickness of the nodule is \<15mm
* Pregnant or lactating woman
* Any contraindication to the assigned analgesia/anaesthesia.
Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission.

To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.

Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often of the IgM class, can be detected in the serum and/or urine of most patients with CLL. Unique cell surface markers are increasingly being used to diagnose the disease, and in approximately 40% of patients, cytogenetic abnormalities (for example, trisomy 12) can be found. Patients commonly present with lymphocytosis, lymphadenopathy, splenomegaly and symptoms of fatigue, weight loss, and malaise. In more advanced cases anemia and thrombocytopenia can also occur. The clinical course of CLL is unpredictable, with survival from initial diagnosis varying from 1 to 20 years (2). In addition, there is a subset of patients with indolent CLL whose absolute lymphocyte count is less than 30 x 109/L and who rarely die from the disease.

CLL is commonly staged according to the 5-point system proposed by Rai (Appendix B) and co-workers. While Rai staging is a relatively good predictor of overall survival, it cannot predict the prognosis in individual patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years old.
* Signed informed consent.
* Zubrod performance status of 0, 1, or 2 (Appendix C).
* Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical complete remission by NCI-WG criteria with chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have documentation of residual disease by immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual population of CD5 and CD19 positive cells that comprise \<10% of the marrow mononuclear cells and have a Kappa/Lambda ratio \>6 or \<.33.
* Patients with CLL who have achieved a partial remission (PR) or nodular partial remission (nPR) by NCI-WG criteria after chemotherapy.
* Creatinine, bilirubin, AST or ALT and alkaline phosphatase ≤2 x the upper limit of normal.

Exclusion Criteria:

* Active infection.
* Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
* Less than 2 months since prior chemotherapy.
* Previous treatment with CAMPATH-1H.
* Pregnant or nursing women.
* Patients on corticosteroids.
* Uncontrolled autoimmune hemolytic anemia.
The Circadian Rhythm of Potassium and Cystatin C

The potassium value is important to prevent cardiac arrhythmias and sudden cardiac death. In patients with renal failure, the potassium value is not stable and tends to raise. Until now there are no data available if the potassium value has a circadian rhythm and if there are individual changes from day to day.

Potassium and cystatin c is measured every 2 hours during 24 hours, twice. There are two groups of patients: Patients with eGFR \< 60 ml/min and patients with eGFR \> 60 ml/min

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* normal renal function and impaired renal function (GFR \< 60 ml/min) respectively

Exclusion Criteria:

* pregnancy
* anaemia (Hb\<10 mg/dl)
Growth and Tolerance of Infants Fed Formula for 16 Weeks

Growth and Tolerance Trial of Iron-fortified infant formulas

16 WEEK GROWTH AND TOLERANCE

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants, 37-42 weeks gestational age

Exclusion Criteria:

* Any condition that would negatively impact assessment of growth and tolerance
Ivermectin Nasal Drops in Post COVID-19 Parosmia

The current study will be a pilot study for a randomized controlled trial conducted on patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine To evaluate the effect of ivermectin nasal drops in the treatment of post COVID 19 parosmia

The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study.

To be included in the study, patients should be more than 18 years old, have a history of COVID 19 infection more than three months ago as confirmed by PCR test, have a post COpost-COVIDVID parosmia, and have no history of systemic steroid administration over the last one month. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Ivermectin were the exclusion criteria for this study.

Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. Case group will receive a 4 weeks course of Ivermectin 1% in a dose of two drops per each nostril twice daily. Control group will receive a 4 weeks course of local steroids in the form of budesonide (64 µg per puff in a dose of 1 puff for each nostril twice daily.

Assessment protocol:

Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria. Endoscopic examination of the nasal cavity will be performed to exclude any other intranasal pathology. The degree of parosmia will be assessed using a visual analog scale before and four weeks after treatment.

Outcome measures:

Primary outcome measures will include a comparison between the pre and post treatment values of visual analog scales of parosmia, and a comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement. Secondary outcome measures will include assessment of the side effects of Ivermectin nasal drops among the case group.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be more than 18 years old,
* Patients having a history of COVID 19 infection more than three months ago as confirmed by PCR test,
* Patients having a post COVID parosmia,
* Patients having no history of systemic steroid administration over the last one month.

Exclusion Criteria:

* History of previous nasal surgery,
* Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
* Hypersensitivity to Ivermectin.