cyrilzakka/clinical-trials huggingface dataset:
Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients

In this study, submental ultrasound during awake and simultaneous under Drug-induced sleep endoscopy is applied in the diagnostic workup of obstructive sleep apnea patients. The aim is to assess the tongue base thickness during awake and sleep with different head positions. By correlation with Drug-induced sleep endoscopy findings, more parameters could be used for evaluation and management of upper airway collapse in obstructive sleep apnea patients.

Obstructive sleep apnea (OSA) is a syndrome characterized by recurrent episodes of apnea and hypopnea during sleep that are caused by repetitive upper airway (UA) collapse and often result in decreased blood oxygen levels and arousal from sleep. Successful treatment lies in precise mapping the site of airway narrowing.

Drug-induced sleep endoscopy (DISE) is a well described modality to mimic the dynamic change of UA in OSA patients during natural sleep. Nevertheless, the tongue base thickness (TBT), one of the important anatomic factors in OSA, is hard to evaluate under this method. Recently, submental ultrasound (US), the noninvasive and convenient tool, has been widely applied to measure the TBT in awake OSA patients, so as to predict the severity and relationship with UA collapse. However, few evidence has addressed the relationship between UA collapse and the TBT in different head positions, awake and sleep period In this study, submental US during awake and drug induced sleep period is applied in the diagnostic workup of OSA patients. By correlation with DISE findings, more parameters could be used for evaluation and management of upper airway collapse in OSA patients.

Key Words: Submental ultrasound, Obstructive sleep apnea, Drug-induced sleep endoscopy

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea patients, age between 20-70

Exclusion Criteria:

* severe heart, lung, liver, and kidney comorbidity propofol or dexmedetomidine allergies (albeit rare)
Korea Post Marketing Surveillance (PMS) Study of Talzenna®

Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label)
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
2. Breastfeeding
3. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children

The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).

Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which may become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs; help to evaluate the point at which lung function deviates from normal to allow early intervention before irreversible lung damage occurs and thereby to reduce morbidity and mortality.

Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent publications have demonstrated that the majority of preschool children can produce reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques. This recent development may enable studying the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit.
PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors

The purpose of this first-in-human study of CX-188 is to characterize the safety, tolerability, pharmacokinetics (PK), and antitumor activity of CX-188 in adult subjects with metastatic or advanced unresectable solid tumors that progressed on standard therapy: PROCLAIM: PRObody Clinical Assessment in Man CX-188 clinical trial 001


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed diagnosis of metastatic or advanced unresectable solid tumors that progressed on standard therapy
2. agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. At least 18 years old

Exclusion Criteria:

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
3. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
4. History of or current active autoimmune diseases
5. History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications
6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug
The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.

This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to participation
2. Female and male patient ≥ 40 years of age
3. Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
4. Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio \<70%)
5. Clinical data available 2 years before the study visit
6. Ability to complete CAT - COPD Assessment Test

Exclusion Criteria:

1. Current participation in any clinical trial involving a drug or device
2. A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit
Quadruple Fortified Salt Clinical Trial

Anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa and Asia. Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. With these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.

Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed anaemic if has HB \<11g/dl but in high attitude is =\<13g/dl

Eligibility Criteria:
Inclusion Criteria:

* Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)
* Able to eat food cooked with salt
* Able to give consent

Exclusion Criteria:

* Planning to become pregnant within the study period,
* chronically ill,
* have haematological diseases during study time,
* restricted to use salt in food
Educational Intervention Using SMS to Evaluate Clinical Effects and Satisfaction in Patients With Diabetes Mellitus

The investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group.

Patients with diabetes mellitus (DM) have greater control over the disease when they acquire some knowledge about it. In this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. This study aims to evaluate the impact of these educational approaches via SMS on glycemic control of patients with DM, followed at the Endocrinology Outpatient Clinic of the Antonio Pedro University Hospital (HUAP). Also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. The study included patients diagnosed with DM, respecting the established inclusion and exclusion criteria. Participants were randomized into the control group and the intervention group. The patients in the intervention group received weekly SMS for six months, with dietary guidelines and DM care. Both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for DM. Similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* diabetes

Exclusion Criteria:

* non diabetes
Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters

The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout.


Eligibility Criteria:
Inclusion Criteria:

* patients with and without known pulmonary disease

Exclusion Criteria:

* pregnancy
* inability to participate
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Eligibility Criteria:
Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during the study.
Association Between Sarcopenia and Urinary Incontinence And Effect Of Physical Activity Among Over 50 Years Old Adults

As far as the investigators know, until this moment no research has investigated the prevalence of Sarcopenia in both sexes in Hungary. Additionally, no research discovered the association between sarcopenia and UI and the effect of physical activity level on these geriatric conditions in Hungary.

Furthermore, it is known that Sarcopenia and UI are causing negative psychological, physical, and social effects on the geriatrics who are suffering from these conditions, not to mention the increase in health care costs. In an attempt to decrease these negative effects, there is a need for a deeper understanding of these conditions by identifying the relationship between them and understanding the risk factors that might cause them. The finding of this study would help with determining those risk factors that are causing these geriatric conditions (Sarcopenia and UI).

Last, this study will provide accurate numbers and statistics to the Hungarian health organizations and educational institutions about the prevalence of sarcopenia and UI which will help shed the light on the importance of these problems among older adults in Hungary.

This Cross-sectional study aim to:

1. Explore and study physical activity levels among aging adults of both sexes in Hungary.
2. To determine the prevalence of sarcopenia and UI among elderly individuals in Hungary.
3. Investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years).
4. Identify the effect of physical activity level on the occurrence of Sarcopenia and Urinary incontinence

Hypothesis:

1. The investigators hypothesize that sarcopenia is a risk factor to have UI.
2. The investigators hypothesize that reduced physical activity level is also associated with sarcopenia and/or UI.


Eligibility Criteria:
Inclusion Criteria:

• Any person who is 50 years old or older

Exclusion Criteria:

• Individuals who cannot provide reliable clinical information due to cognitive disorders.

Individuals who are having any neurodegenerative disorders (E.g; Parkinson).
Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL

Immunotherapy has shown promise in treating hematological malignancies, including resistant B-ALL. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain regarding antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including CD19, with CAR-NK cells in resistant B-ALL. To further investigate the potential of anti-CD19 CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard treatment.


Eligibility Criteria:
Inclusion Criteria:

Eligible diseases: Acute lymphocytic leukemia (ALL CD19+). Patients 3 years of age or older, and must have a life expectancy \> 12 weeks. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.

Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR NK cells.

Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.

Ability to give informed consent.

Exclusion Criteria:

Pregnant or nursing women may not participate. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.

Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.

History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.

Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.

The existence of unstable or active ulcers or gastrointestinal bleeding. Patients need anticoagulant therapy (such as warfarin or heparin). Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).

Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.
Competitive Swimming and Shoulder Adaptations: The Role of Stroke Specialty in Adolescent Swimmers

Objectives: To examine the sport-specific adaptations and investigate the effect of swimming stroke specialization in shoulder complex among adolescent competitive swimmers.

Design: Observational study.

Setting: Athletic facilities.

Participants: A total of 76 adolescents participated including n = 28 non-swimmers as Control Group (CG) and n = 48 competitive swimmers as Swimmers Group (SWG).

Main Outcome Measures: Strength of glenohumeral (GH) and scapular muscles (SM), mobility of GH (GH ROMs) joint, proprioception, pectoralis minor length (PML), posterior shoulder tightness (PST) were evaluated for all participants. Kerlan Jobe Orthopaedic Score (KJOC) was sed to evaluate for SWG. The tested shoulder physical performance parameters were compared between the groups.


Eligibility Criteria:
Inclusion Criteria for Swimmer Group:

* aged between 13 to 18 years
* the asymptomatic swimmers with no history of major upper limb injury or surgery and no injury history of upper limb in last 6 months
* having experience in at least 5 years competitive swimming,
* actively participating in competitive swimming at least 1 year,
* competing at least in national level and having swimming stroke specialization in competitive swimming

Inclusion Criteria for Control Group:

* aged between 13 to 18 years,
* no competed in overhead sports like swimming, basketball, volleyball, tennis, baseball as professional or recreational,
* no history of major upper limb injury or surgery in last 6 months.

Exclusion Criteria for all participants:

* if they had at least two positive signs by shoulder screening tests (Hawkin's/Kennedy Subacromial Impingement Test, Jobe/Empty Can Test, External Rotation Resistance Test, Apprehension Instability Test, Speed Test and Gerber Lift-Off Test),
* a BMI of 30 kg/m² or greater than 30 kg/m²,
* competing in paralympic sports,
* if they had any major upper limb injuries or surgeries,
* if they had any systemic, neurological or rheumatological diseases,
* being pre-pubertal stage (Tanner I) according to Tanner Scale,
* indicated their unwillingness to participate to this study.
Survey of Human Rabies Immune Globulin Safety in Children

This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.

BACKGROUND: Rabies PEP consists of thorough wound cleansing, administration of HRIG 20 IU/kg body weight, and 4 to 5 doses of rabies vaccine. The safety of HRIG 300 IU/mL has been confirmed only for adult patients. Although the safety of HRIG 300 IU/mL in the pediatric population has not been fully established, there is no age limit on the FDA approved indication for HRIG 300 IU/mL, and it is routinely administered to pediatric patients as standard of care in the United States.

STUDY DESIGN: This observational, multicenter, prospective study will collect information on safety events that occur up to 30 days after standard of care administration of HRIG 300 IU/mL among pediatric patients (age ≤17 years) at up to 5 study sites in the United States. Safety data will be collected using surveys and chart review of the health record. All participants will receive HRIG 300 IU/mL per standard of care prior to joining this study. The day of HRIG 300 IU/mL administration will be defined as day 0. The study will conduct Survey 1 on day 2 and Survey 2 on day 10 to collect information on adverse events (AEs). Investigators will review the electronic health record on day 30 to collect additional information on AEs. If a serious adverse event is detected during Survey 1, Survey 2, or the 30-day chart review and is not previously documented as being resolved or stabilized the study will conduct Survey 3 on day 30.

Eligibility Criteria:
Inclusion Criteria

1. Received HRIG 300 IU/mL for rabies PEP during an ED encounter visit
2. Aged ≤17 years

Exclusion Criteria

1. HRIG 300 IU/mL dose given is \<18 IU/kg or \>22 IU/kg
2. Patient is admitted or transferred to a hospital from the ED for further management of injuries related to the animal exposure
3. Patient has a history of rabies vaccine or rabies immune globulin administration
4. Legally authorized representative (parent) does not speak English if patient is \<7 years old
5. Legally authorized representative (parent) or patient does not speak English if patient is 7 to 17 years old
6. Inability to obtain consent

   1. More than 3 days passed since HRIG 300 IU/mL administration prior to screen
   2. Unable to contact legally authorized representative (parent) and/or patient within 3 days of HRIG 300 IU/mL administration
   3. Legally authorized representative (parent) and/or patient declined participation
7. Administration sites for HRIG are unknown