cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Obstructive Sleep Apnea

Rapid maxillary expansion (RME) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.The aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne RME appliances on sleep quality with polygraphy. The null hypothesis was that there is no difference for the sleep quality between the appliances.

Introduction. The aim of this 3-arm randomized controlled trial (RCT) was to evaluate the effects of tooth tissue-borne (KBME), tooth-borne (Hyrax), and bone-borne (MIDME) rapid maxillary expansion (RME) appliances on sleep quality with polygraphy. Methods. This study was designed in parallel with an allocation ratio of 1:1:1. 46 patients with narrow maxilla and OSAS were included in this study and randomly assigned to three groups: tooth tissue-borne, tooth-borne and boneborne expanders. Participants were congregated from the Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Turkey. In all groups, the expansion appliance was activated one-quarter turn twice a day until the desired suture opening was achieved. The primary outcome of this study was the correction of posterior crossbite. Secondary outcomes included polygraphic assessment of sleep parameters. Each subject participated in 1 overnight sleep test with polygraphy before the expansion (T0) and after a 3- month retention phase of treatment (T1). According to the results of polygraphy, 7 parameters; (apnea hypopnea index (AHI), number of apnea and hypopnea, desaturation index, lowest desaturation, average saturation, supin AHI) were examined to evaluate the changes in sleep scores. Kruskal-Wallis analysis and Dunn-Bonferroni test were used for inter-group comparisons and Wilcoxon analysis was used for intra-group evalaution. P\<0.05 was accepted statistically significant. Computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. The outcome assessor was blinded to group assignment. The outcome assessor was blinded; however, it was not feasible to blind either operator or patients.

Eligibility Criteria:
Inclusion Criteria:

1. No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
2. Bilateral crossbite and need for RME,
3. Maxillary and mandibular permanent teeth fully erupted,
4. AHI ≥ 1

Exclusion Criteria:

1. The presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
2. Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
3. History of previous orthodontic treatment.
Clinical Trial of Mitoxantrone HCL Liposome Injection in Patients With Relapsed DLBCL and PT/NKCLs

To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with diffuse large B-cell lymphoma and lymphoma peripheral T cell.

A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Diffuse Large B-cell Lymphoma and and Peripheral T/NK Lymphomas with dose of 20 mg/m2.

Eligibility Criteria:
Inclusion Criteria:

* The subjects are voluntary and sign the informed consent form;
* ECOG score 0 to 2;
* The expected survival time ≥3 months;
* Diffuse large B-cell and peripheral T/NK cell non-Hodgkin's lymphomas confirmed with histopathology, and the peripheral T/NK cell lymphomas that are only limited to the following types: peripheral T-cell lymphoma (not otherwise specified), angioimmunobl;
* Failure or relapse after at least once of systemic treatment, and patients who can not receive autologous peripheral blood stem cell transplantation
* The major diameter of a single measurable lesion ≥1.5 cm in at least one measurable lesion;
* An interval of at least four weeks after the target tumor was treated with chemotherapy, radiotherapy, biological therapy, stem cell transplantation or other study drugs;
* Subjects at childbearing age agree to take effective contraceptive measures during the study; blood pregnancy test result is negative (except infertility due to menopause or operation);
* Laboratory tests (blood routine, liver and kidney function) meet the following requirements:

  * ANC≥ 1.5×109/L, for those with bone marrow involvement, ANC ≥ 1.0×109/L;
  * PLT ≥ 75×109/L, for those with bone marrow involvement, PLT ≥ 50 × 109/L;
  * Hb ≥ 9 g/dL; d) Cr) ≤ 1.5x ULN ;
  * TBIL ≤ 1.5x ULN;
  * AST or ALT ≤2.5 x ULN (for patients with liver metastases, ≤ 5 x ULN ).

Exclusion Criteria:

* Pregnant or lactating women;
* An allergic history to anthracyclines or liposome drugs;
* Disease progression or recurrence after anthracycline treatment within six months before the enrollment;"
* Patients who once used mitoxantrone injection;
* Patients who have used doxorubicin (or pirarubicin) with the total cumulative dose\> 360mg/m2, or epirubicin with the total cumulative dose \> 600mg/m2;
* Left ventricular ejection fraction is \< 50% or \< the lower limit of normal; clinically significant QT interval prolongation (\>450ms in male, \>470ms in female); a past history of cardiac disease caused by anthracyclines; a history of severe heart disease;
* Concomitant treatment as other anticancer drugs are needed;
* Lymphoma involving the central nervous system;
* Clinically active infection that can significantly affect the clinical trial;
* Within 6 weeks after organ transplantation or major organ surgery;
* Those who are inappropriate to be enrolled as evaluated by the researchers.
Experience of Rehabilitation Amongst Individuals With Paraplegia

This study is a qualitative study exploring the facilitators to physical and vocational rehabilitation and also explores the barriers in empowering individuals with paraplegia

Spinal cord injury is one of the most distressing medical conditions being encountered by today's health care system. In India incidence of Spinal cord injury accounts for 20 per million per years population with 20,000 cases added every year. Rehabilitation services are of utmost importance in empowering these individuals. So there is a need for more qualitative studies through which needs in rehabilitation services can be upgraded. The aim of the study is to explore the experience of physical and vocational rehabilitation amongst the individuals with paraplegia in India

Eligibility Criteria:
Inclusion Criteria:

* Traumatic \& Non-Traumatic paraplegics Both male \& female above 18 yrs of age Time since injury of minimum 6 months Community dwelling paraplegics

Exclusion Criteria:

* Communication problems Psychiatric problems or co morbidities like head injury
Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Patients With Relapsed AML After Transplantation

This is an open single-arm clinical study aimed at evaluating the efficacy and safety of universal γδT cell injection in the treatment of patients with relapsed AML after transplantation

Main purpose: To evaluate the safety and effectiveness of universal CAR-γδT cell injection in the treatment of patients with relapsed AML after transplantation

Secondary purpose: to investigate the in vivo dynamics characteristics of universal CAR-γδT cells after infusion and explore reasonable therapeutic doses through climbing tests in different dose groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically diagnosed recurrence of AML after receiving transplant therapy;
2. Flow cytometry (FCM) or immunohistochemical detection of tumor cells confirmed CD123 positive;
3. Age ≥2 years old and \<65 years old;
4. Survival is expected to be greater than 3 months from the date of signing of the informed consent;
5. KPS 80 points or more;
6. The functions of vital organs shall meet the following conditions:

1) EF\>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN; 7. Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant; 8. Subject or guardian understands and signs the informed consent;

Exclusion Criteria:

* 1. Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness; 2. Other active malignant tumors; 3. Complicated with severe infection that cannot be effectively controlled; 4. Active hepatitis B (HBVDNA) or HCV RNA \[HCVRNA\] test was positive); 5. Human immunodeficiency virus (HIV) infection or syphilis infection; 6. Have a history of severe allergy to biological products (including antibiotics); 7. Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients; 8. Female subjects are in pregnancy and lactation; 9. Active autoimmune diseases requiring systemic immunosuppression; 10. Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.


Eligibility Criteria:
Inclusion criteria:

* Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th edition (R12-4710)
* Evidence of common EGFR mutation (Del 19 and/or L858R)
* Age \>= 70 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)
* Further inclusion criteria apply.

Exclusion criteria:

* Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
* Prior systemic therapy for metastatic or recurrent NSCLC.
* Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
* Radiotherapy within 4 weeks prior to start of study treatment, except as follows:

  * Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or
  * Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  * Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
  * Systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
* Men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended.
* Further exclusion criteria apply.
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract

The purpose of prospective cohort study is to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract(CC) and to explore key factors associated with the rate of change.

Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital cataract. The developmental profile of refraction among patient with congenital catarat is has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC children.After primary IOL implatation, routine examinations including retinoscopy were completed. Data were analysed to to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract and to explore key factors associated with the rate of change.

Eligibility Criteria:
Inclusion Criteria:

* Children with uncomplicated surgeries
* Children with unilateral/bilateral cataract

Exclusion Criteria:

* Corneal diseases
* Lens luxation
* Glaucoma
* Retinal diseases
* Nystagmus and nanophthalmos
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy women ≥ 21 years old
* Using contraception if of reproductive age

Exclusion Criteria:

* Pregnant, recently pregnant or actively trying to conceive
* Prior hysterectomy
* Current or recent urinary tract or vaginal infection
Essential Acute Stroke Care in Low Resource Settings: a Pilot studY

An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting

This is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. Patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). This will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. Patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years)
* A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset
* Provision of written informed consent
* Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.

Exclusion Criteria:

* Patients who have undergone intravenous thrombolysis or mechanical thrombectomy
* Patients who are planned for transfer to the intensive care unit
* Subarachnoid haemorrhage
* Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.
Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder

Phase II Trial of concurrent administration of intravesical BCG \& Interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.


Eligibility Criteria:
Inclusion Criteria:

* Patients with superficial transitional carcinoma of the urinary bladder
COVID-19 Risk Reduction Among African American Parishioners

African American adults, specifically those managing chronic disease and social isolation, are one of the most vulnerable groups susceptible to COVID-19. This intervention involves a multi-disciplinary and culturally sensitive approach to address two major COVID-19 related challenges in this population. First, this program collaborates with predominantly African American churches to implement Federal and State guidelines aimed at preventing outbreaks of COVID-19 at faith-based gatherings. Second, this program trains church-based health advisors to help African American older parishioners manage their chronic health conditions and reduce psychological distress during the pandemic.

To jointly implement and evaluate a telehealth-based, multidisciplinary, culturally-sensitive intervention with 265 AA older parishioners: (i) To mitigate the negative impact of COVID-19 on the management of chronic health conditions, and (ii) to reduce healthcare avoidance behaviors and psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* African American older adults aged 55 years with a chronic medical condition or 65years and older
* Have at least one risk factor for COVID-19

Exclusion Criteria:

* Resident of care facility
* Cognitive deficit (identified by short version of mini-mental instrument)
* Does not self-identify as African American and/or Black
* Under the age of 55years
* Unable to speak and/or read English
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression

This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
* Age 18-75
* Use of effective method of birth control for women of child-bearing capacity
* Willing and capable of providing informed consent
* Convulsive therapy clinically indicated
* Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)

Exclusion Criteria:

* Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
* Pregnancy
* History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, or structural brain lesion
* Presence of devices that may be affected by rTMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* Breast-feeding
* History of head trauma with loss of consciousness for greater than 5 minutes
* History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
* Vagus Nerve Stimulator implanted
* History of substance abuse or dependence in past 3 months
* Failure to respond to an adequate course of ECT in the current depressive episode
* History of ECT in the past 6 months
Transient Circulatory Support in Cardiogenic Shock

The purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. Some studies described patients with TCS in order to establish mortality predictive scores (ENCOURAGE, SAVE), but no study has assessed the clinical relevance of the TCS decision yet. Therefore, The investigators propose to compare the characteristics and the follow-up of patients in acute cardiogenic shock, once TCS implantation was decided or not by the heart team.

This French multicenter prospective observational study is aimed at determining if the decision of transient circulatory support (TCS) in cardiogenic shock is pertinent, i.e. at least as effective as the medical treatment.

All patients with cardiogenic shock for whom indication of TCS was discussed within the multidisciplinary heart team (cardiologist, intensivist and cardiac surgeon) are consecutively included in the study.

Two groups of patients are defined:

* Patients with cardiogenic shock treated by medical treatement
* Patients with cardiogenic shock treated by TCS (extracorporeal circulatory life support and/or Impella).

The main objective is to compare mortality between the 2 groups. Secondary objectives are ICU follow-up characteristics and quality of life questionnaire at day 180.

Statistical analysis will include a propensity-matched method to compare the groups to avoid confounding factors. The number of necessary subjects (n=240, 120 in each group) was calculated assuming that TCS has a superiority of 20% in comparison with medical treatment in severe cardiogenic shock, with a study power of 80%, and an alpha risk of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Cardiogenic shock :

  • Systolic BP\<90mmHg despite adequate filling pressure
* Or need of cathecolamines to maintain SBP \> 90mmHg

  * Signs of right-sided and/or left-sided congestion
  * Signs of tissue hypoperfusion : oliguria, cold sweated extremities, mental confusion, dizziness, narrow pulse pressure, blood lactate \> 2 mmol/L
* Short-term mechanical circulatory support discussed by the multidisciplinary heart team

Exclusion Criteria:

* Post cardiotomy cardiogenic shock
* Refractory cardiac arrest
* Cardiac Arrest with No Flow \>3 min and/or non shokable rythm
* Contraindication to transient circulatory support because of comorbidities, neurological dysfunction, severe end-organ failure or aortic regurgitation
* Pregnant or brest-feeding women,
* Age \< 18 year-old
Clostridioides Difficile and Frailty

CDI is a major cause of antibiotics-associated diarrhoea. More than half of the patients affected are 70 years or older and frail. Mortality among older patients with CDI is high. Faecal microbiota transplantation (FMT) is a life-saving therapy which reduce symptom duration and mortality. The FMT procedure usually requires hospital attendance, and frail old patients often are too weak to tolerate transportation to hospital and may therefore be withheld treatment.

The overall aim of the present project is to investigate whether a multimodal geriatric assessment, treatment and follow-up of frail older patients with CDI can improve patient survival compared with standard care. In particular, it is explored whether an expanded collaboration between the geriatric wards, early clinical assessment and home treatment with FMT contribute to increased patient survival rates.

This is a multi-centre randomised clinical trial that test two established care pathways in the assessment and treatment of old patients with Clostridioides difficile infection (CDI). We aim to include 216 patients aged 70 years or older with Clostridioides difficile infection. Patients are randomised in a 1:1 ratio to either geriatric tailored intervention or standard care as defined by national clinical guidelines. The primary outcome is 90-day survival.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 70 years and living in the Central Denmark Region
2. Positive PCR test Clostridioides difficile

Exclusion Criteria:

1. Previously included
2. \> 4 episodes of CDI
3. FMT treatment 8 weeks before date of positive PCR test for Clostridioides difficile.
4. End of life care defined as follows: end of life care treatment has been initiated before positive PCR test for CDI and the patient has days/few weeks of survival (investigator consensus based on review of electronic medical journal (EMR))
5. Patients already received Comprehensive Geriatric Assessment, defined as follows: when diagnosed with CDI affiliated with the Department of Geriatrics (in- or outpatient activity).