cyrilzakka/clinical-trials huggingface dataset:
Screening of Dysphagia Via Ultrasonography in Patients With Stroke

Oropharyngeal dysphagia is commonly seen in patients with stroke. Clinical assessment may be used to evaluate dysphagia in patients with stroke however reliability of this method is controversial and videofluoroscopic study is still considered as gold standard. However, exposure to radiation, necessity for a experienced practitioner, an expensive device, and swallowing contrast agents are disadvantages of videofluoroscopy. Ultrasonography, on the other hand, is a cheap, noninvasive device which may demonstrate tongue and laryngeal movement dynamically. In this manner, this study aims to evaluate whether ultrasound can assess dysphagia in patients with hemiplegia accurately.

For a safe swallowing tongue muscles must function properly and larynx should replace superoanterior to close trachea via stretching cricopharyngeal muscle. In this context, approximation of thyroid cartilage and larynx is important for swallowing. These mechanisms are impaired in stroke, Parkinson's disease, traumatic brain injury, and neuromuscular disorders thus resulting oropharyngeal dysphagia. Clinical examination may be used for assessing dysphagia in those patients however reliability of this method is controversial and videofluoroscopic study is considered as gold standard for assessing dysphagia. Ultrasound is used to assess swallowing functions since 1970s however, the studies commonly focused on tongue thickness and functions. Due to advances in technology besides tongue thickness, ultrasonography may practically demonstrate how larynx and thyroid cartilage approximate and hor larynx moves anteriorly. In literature, three methods came to forefront as evaluation methods for dysphagia: 1) approximation of thyroid cartilage and hyoid bone (THA), 2) tongue thickness in rest (TT), and 3) hyoid bone anterior replacement (HAR). In previous studies, the efficiency of THA for assessing dysphagia via videofluoroscopic study has been demonstrated. However other methods have not been evaluated in dysphagic patients with stroke. Ultrasonography, as a cheap, portable and non-invasive method, is a promising for assessing dysphagia in patients with stroke. In this context, this study aims to test the reliability and efficacy of these three methods via ultrasound in dysphagic stroke patients and test the performance of ultrasound compared to videofluoroscopy.

Eligibility Criteria:
Inclusion Criteria:

* stroke diagnosis
* aged 18-75
* dysphagia assessed by bedside examination (phase 1: wet voice or cough after drinking 5 ml clear water is positive, phase 2: if phase 1 is negative, inability of drinking 60 ml of water in 2 minutes without coughing or wet voice is positive)

Exclusion Criteria:

* unable to consent due cognitive dysfunction
* unable to cooperate with videofluoroscopic study
* dysphagia before stroke
* rheumatologic or neuromuscular disorder that may cause dysphagia
Weight Regain Treatment Post-Bariatric Surgery

This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Be in the age range ≥18 years of age and ≤70 years of age
* Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and ≤50 kg/m2
* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
* Experiencing weight regain after bariatric surgery
* Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
* Read, comprehend, and write English at a sufficient level to complete study-related materials.
* Provide a signed and dated written informed consent prior to study participation.
* Be available for participation in the study for up to 3 months.

Exclusion Criteria:

* Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
* Has a history of anorexia nervosa or history of bulimia nervosa.
* Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
* Is currently using other medications for weight loss.
* Has a history of allergy or sensitivity to bupropion or naltrexone.
* Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
* Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute.
* Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
* Has current uncontrolled hypertension.
* Has current uncontrolled Type I or Type II diabetes mellitus.
* Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.
* Has gallbladder disease.
* Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
* Has a recent history of drug or alcohol dependence (since having bariatric surgery).
* Is currently in active treatment for eating or weight loss.
* Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
* Is breast-feeding or is pregnant or is not using a reliable form of birth control.
* Reports active suicidal or homicidal ideation.
Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography

Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion.

The results of this study will help defining the capability and reliability of PulmoVista® 500 (PV500) to detect changes in both global and regional ventilation and perfusion. As this is a non-invasive, observational trial, neither a positive nor a negative impact on the actual study participants is expected. The results will, however, improve the knowledge about the electrical impedance tomography (EIT) technology and thus aid the use of this technology for the benefit of future patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years
* Mandatorily ventilated intensive-care patients with impairment in oxygenation (P/F ratio \< 300 at PEEP ≥ 5) ventilated at a positive end-expiratory pressure (PEEP) not exceeding 10 mbar and an fraction of inspired oxygen (FiO2) chosen, such that pulse oximetry is sensitive towards arterial oxygen pressure (PaO2) changes.
* Expected ventilation time \>48h
* Existing central venous and arterial access
* Chest circumference 70 - 150 cm
* Mandatory mechanical ventilation (patients without spontaneous efforts)
* Serum levels of sodium and chloride within normal range
* Cardiac output monitoring in place (PICCO)

Exclusion Criteria:

* Contraindication to central venous injection of 5 % sodium chloride (NaCl) (e.g. elevated Na+ and/or Cl- concentration: Na+ should not exceed 150 mmol/l, Chloride should not exceed 115 mmol/l, known hypernatremia, known high serum osmolality)
* Contraindications of PulmoVista 500:

  * Patients with pacemakers, defibrillators or other electrically active implants
  * Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
  * Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures
  * Patients with uncontrolled body movements
  * Extremely obese patients (BMI\>50)
  * Patients during pregnancy
  * Patients with massive lung edema
  * Use during electricity-based therapies, such as electrosurgery or electrocautery
  * Use in the presence of strong magnetic fields
  * Use in conjunction with other bioimpedance measurement devices
* Infection or colonization with multi-resistant pathogens that require isolation of the patient (e.g. MRSA)
Evaluation of an Oral Nutritional Supplement

The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Age ≥ 60 and ≤ 90 years
2. Body Mass Index (BMI) \> 20 but \< 35

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. History of diabetes
2. Currently taking or has taken antibiotic within 1 week prior to enrollment
3. Major surgery less than 3 months prior to enrollment in the study
4. Current active malignant disease or was treated within the last 6 months for cancer
5. Immunodeficiency disorder
6. Myocardial infarction within the last 3 months prior to enrollment
7. Chronic obstructive pulmonary disease (COPD)
8. Allergy to any of the ingredients in the study product
9. Aversion to flavor of product being tested
10. Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease
11. Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
12. Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
13. Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility
Weight Loss Effects on Heart and Blood Vessel Function in Obesity

Obesity is a growing epidemic and is associated with an increased risk of heart attack and stroke. The investigators know that obesity leads to abnormalities in how the blood vessels and the heart function and that these abnormalities are an important cause of this increased risk in obese individuals. While improvements in these abnormalities have been reported with marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is not clear that these abnormalities can be substantially reversed with standard dietary interventions. Additional information is needed regarding the degree of weight loss required, the time course of these improvements, nor the mechanisms. All of these have major implications for the potential role of weight loss in the management of these patients.

The investigators will assess the effects of dietary induced weight loss in both the short and long term on the function of blood vessels and the heart, and the relationship of any changes with markers of inflammation that are present in obesity.

By understanding the factors that are important in reversing these abnormalities in obesity the investigators will be better to identify and reduce heart attack and stroke in obese individuals in the future.


Eligibility Criteria:
Inclusion Criteria:

* Obese Caucasian men age 18-65 years, who are non smokers, and consuming 2 or fewer standard alcoholic drinks per day (on average over the past 5 years) will be recruited.
* Obesity, for the purposes of this study, is defined by a BMI \> 30 and a waist circumference \> 102 cm.
* Caucasian men only are enrolled because the cut-off points for the definition of obesity vary significantly by race.

Exclusion Criteria:

* Men are excluded if they have any previously diagnoses or symptomatic atherosclerotic disease, or are taking any cardiovascular medication.
* Men with known gallstones, history of gout, or any contraindication to MRI are also excluded.
INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and antitumor activity of INCB001158 in combination with daratumumab SC, compared with daratumumab SC alone, in participants with relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of multiple myeloma according to IMWG diagnostic criteria.
* Measurable disease at screening.
* Has received at least 3 but not more than 5 prior lines of multiple myeloma treatment, including proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapies.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Willing to avoid pregnancy or fathering children.
* Willing to provide fresh and archival bone marrow aspiration and biopsy tissue.

Exclusion Criteria:

* Receipt of any of the following treatment within the indicated interval before the first administration of study drug:

  * Anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer).
  * Investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks.
  * Autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time.
  * Plasmapheresis within 4 weeks.
  * Radiation therapy within 2 weeks.
  * Major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment.
* Toxicity ≥ Grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
* Known additional malignancy (other than multiple myeloma) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
* Laboratory values at screening outside the protocol-defined range.
* Significant concurrent, uncontrolled medical condition including but not limited to known chronic obstructive pulmonary disease (COPD), persistent asthma, or history of asthma within the past 2 years; chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment; acute diffuse infiltrative pulmonary disease; clinically significant or uncontrolled cardiac disease.
* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis.
Change of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy

This study was designed to examine the effect of incentive spirometry in pulmonary rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can help improve breathing and strengthen inspiratory muscles. If the patient assigned to training group, the subjects started to respiratory muscle strengthening exercise using incentive spirometry. The training was performed ten sessions daily, for 4 weeks. Respiratory function tests including forced vital capacity, forced expiratory volume in 1 second, Peak cough flow, maximal phonation time were compared before interventions and at the end of exercise.


Eligibility Criteria:
Inclusion Criteria:

* male or female, 4 to 18 years
* patients who are committed to comply with protocol-required procedures
* GMFCS (Gross motor function classification system) level II, III, IV
* Stable medical condition in the investigator's opinion
* Acceptable chest radiologic result who has no evidence of pulmonary disease

Exclusion Criteria:

* Any uncontrolled clinically significant medical condition other than the one under study
* Patients with cognitive impairment who are unable to comply with protocol-required procedure
* Patients with presence or history of tracheostomy
* Patients who are taking medications that can affect respiratory function
A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis

A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to \< 17 years of age.


Eligibility Criteria:
Inclusion Criteria:

* male or females 12 to \< 17 years of age
* Have a confirmed diagnosis of plaque psoriasis
* Negative pregnancy test
* Group 1: Have plaque psoriasis with an IGA score of ≥ 2 (mild), with at least one lesion ) and up to 20% Body Surface Area (BSA) involvement not including psoriasis on the face and scalp
* Group 2: Have plaque psoriasis with a IGA score of ≥ 2 (mild), with plaque psoriasis involving at least 10% and up to 20% Body Surface Area (BSA) not including psoriasis on the face and scalp

Exclusion Criteria:

* known allergy or intolerance to the study drug or other vitamin D3 analogs or any of its components
* history of or active generalized guttate, pustular or erythrodermic exfoliative psoriasis
* history or presence of contact dermatitis induced by a topical medicine or other serious skin condition that is not well controlled
* Use topical treatments known to have beneficial effects on psoriasis
* Use phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate within 30 days prior to the first dose of study drug
* Use any approved biologics for psoriasis within 30 days or 5 half-lives of the biologic before the first dose of study drug
* Are treated with medications known to worsen psoriasis
* Are taking an oral vitamin D
* Are taking medications that affect calcium metabolism;
* Subjects who have an average of three (3) QTcF measurements of \> 450 milliseconds as shown on the ECG (Group 2 only);
* Have clinically significant abnormal calcium homeostasis parameters at Visit 1;
* Have clinically significant liver or renal dysfunction
* Have any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions which that would place the subject at increased risk or would confound the primary or secondary objectives of the study;
* Use of any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of study drug or are taking part in a non-medication study which, that would interfere with study compliance or outcome assessments;
* Are pregnant or lactating females;
* Have a known history of congenital or acquired immunodeficiency.
The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy

For diabetic patient with persisted albuminuria under the intensive control on blood pressure and blood glucose, the non-invasive method of acupressure at Sanyinjiao (SP6) is easy to use and significantly effect on albuminuria reduction in patients of diabetic nephropathy.


Eligibility Criteria:
Inclusion Criteria:

1. age between 20 and 80 years old;
2. HbA1c was lower than 9% according to the NGSP(National Glycohaemoglobin Standardisation Programme);
3. estimated glomerular filtration rate (eGFR) was more than 60 mL/min/1.73 m2.

Exclusion Criteria:

1. Hyperglycemic crisis, including HHS(hyperglycemic hyperosmolar syndrome) and DKA(diabetic ketoacidosis );
2. Persist diabetes poorly control, Hemoglobin A1c \[HbA1c\] \>9%;
3. Endocrine disorders: such as abnormal function of thyroid, pituitary, and sex glands;
4. heart diseases:such as arrhythmia, myocardial infarction, heart failure, or installed pacemaker;
5. immune and allergic diseases: such as systemic lupus erythematosus and asthma;
6. liver or kidney dysfunction: GOT or GPT(glutamate-pyruvate transaminase ) \> 80 IU/L, eGFR\<60 (mL/min);
7. pregnant or lactating women;
8. less than 6months postpartum;
9. acute illness, fever, Lower urinary tract infection, NSAID(nonsteroidal antiinflammatory drug) administration;
10. physical dysfunction because of stroke.
Anti-factor Xa Based Venous Thromboembolism Prophylaxis

Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above


Eligibility Criteria:
Inclusion Criteria: Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h.

-

Exclusion Criteria: Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance \< 30 mL/min.

-
Characterization of Children with Complaints of Excessive Daytime Sleepiness

10% of the population suffers from excessive daytime sleepiness. This can be explained by a variety of etiologies: psychiatric disorders, altered sleep quantity or quality, hypersomnia... The consequences on quality of life are not negligible, with emotional, academic, social, financial and somatic repercussions. Diagnosing and managing them is essential. This is the role of the HFME's Child Sleep Service, a reference center for rare narcolepsy and hypersomnia, which carries out a weekly hypersomnia assessment. In this context, the investigators are carrying out a retrospective descriptive study, the primary objective of which is to describe the results and diagnoses of hypersomnia check-ups in the HFME's Sleep Department, in order to obtain feedback on the center's activity and its evolution.

The secondary objectives are to characterize the patients in the different diagnostic groups, to highlight factors associated with the different diagnoses, and to describe changes in patient characteristics over time.


Eligibility Criteria:
Inclusion Criteria:

* - Patient hospitalized in the HFME sleep department for a "diagnostic assessment of hypersomnia".
* Age under 18 at the time of hospitalization
* From January 2015 to December 2023

Exclusion Criteria:

* - No balance sheet
* Age over 18 at time of hospitalization
* Assessment for medicolegal or therapeutic adaptation purposes