cyrilzakka/clinical-trials huggingface dataset:
Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients

The purpose of this study is to assess feasibility and potential effectiveness of two different music interventions for managing delirium symptoms in acute geriatric patients.

Delirium is a neuropsychiatric syndrome characterized by an acute alteration in attention, awareness, arousal and cognition, precipitated by an acute illness, intoxication, trauma or surgery. It is highly prevalent in older, frail and acutely hospitalized patients, and associated with poor outcomes, with few effective treatment alternatives. Non-pharmacological interventions and music show promising effects.

This study protocol aims to determine whether music interventions (MIs) delivered by a credentialed music therapist, are feasible and effective for regulating delirium symptoms in acute geriatric patients and whether the standardized delirium tools are sensitive to detect observable responses. Primary, feasibility outcomes are evaluating recruitment rate, treatment fidelity and adherence, as well as feasibility and accuracy in data collection procedures. Main effect-outcome is delirium severity, but delirium duration, cognitive status, length of hospital stay, and medication use will also be recorded. The randomised repeated measures controlled trial design will record the participant responses before and after exposure to MIs (+/- 2 hours). Participants with delirium from an acute geriatric ward will be randomized to either live or recorded MI. Each intervention will be delivered to n=30 participants (n=60 in total), for 30 minutes, over three consecutive days. Ethical approval has been obtained from Regional Ethics Committee South East Norway.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 65 and with delirium or possible delirium at admission or detected within the last 72 hours, and still present.
* Appropriate informed consent is obtained.
* Participants will not be excluded if they are under long term care and have comorbidities such as dementia or mild cognitive impairment.
* Patients will not be excluded if they have Covid-19.

Exclusion Criteria:

* Patients who were previously enrolled, and were readmitted during the study period will not be re-included.
* The patients with severe hearing impairments, severe psychiatric conditions, and/or severe alcohol/substance addiction where that is the main reason for admission will be excluded.
* The patients whose assessed musical preferences involve orchestral or other kinds of music which cannot be performed live by voice and a guitar.
Real-world Observation of Medical Accuracy of a Novel AI-app

This study aims to evaluate the performance of the suggestions made by the WRA by comparing Ada's list of suggested conditions and advice level to usual care and a gold-standard in a Romanian clinical setting.

This pilot study investigates the performance of the Romanian version of Ada's Waiting Room Application in a clinical setting. The study will take place in a family doctor's practice in Cluj-Napoca, Romania. While waiting for their consultation with a family doctor, participants will complete an Ada assessment. The results of this assessment will not be available for viewing by the participants or the family practitioner. During and after consultation, the family practitioner will create two top 5 differential diagnoses list--one based on symptoms only and one based on physical examination and investigation results. The accuracy and comprehensiveness of Ada's differential diagnoses will be compared against the family practitioner's and a gold-standard.

Eligibility Criteria:
Inclusion Criteria:

* All patients under 60 years of age that enter the study sites and that are willing/able to provide consent will be included in the study, unless exclusion criteria are met.

Exclusion Criteria:

* Patients with severe injury/illness requiring immediate treatment
* Patients with traumatic injury
* Patients incapable of completing a health assessment (e.g. due to illiteracy, mental impairment or inebriation or other incapacity)
* Patients that are unfamiliar with mobile applications
* Patients that are seeking treatment for a chronic condition
Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD

Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.


Eligibility Criteria:
Inclusion Criteria:

* The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.

Exclusion Criteria:

* The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.
Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia

Iron and vitamin D are two essential micronutrients for the normal growth of young children, and their deficiencies are still a major health problem in developing countries, including Indonesia. A significant association between vitamin D deficiency and anemia has been reported throughout the world. Several studies in various populations all over the world suggest a high degree of association between Iron deficiency anemia and vitamin D deficiency. It is still controversial which deficiency causes the other but this association should be addressed in view of a better treatment proposal. The aim of the present study was to determine the effect of vitamin D supplementation on iron status in iron deficiency anemia.

This research is a randomized controlled trial study conducted in Makassar, South of Sulawesi, Indonesia from April to October 2023. This study was conducted on children with a diagnosis of iron deficiency anemia. Patients were divided into two groups, namely group A which received standard therapy (Fe preparations) 3 mg/kgBW/day, and group B (which received standard therapy combination vitamin D, 400IU).

The inclusion criteria in this study were children aged 1-5 years, diagnosed with iron deficiency anemia, and parents/caregivers willing to include their children in this study. Children who had received iron preparation, and previous blood transfusion were excluded in this study. Patients who refused blood tests after giving therapy for 4 weeks were declared dropouts.

Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and complete blood count (CBC) analysis were carried out: hemoglobin (Hb), Red Blood cell (RBC), Mean erythrocyte volume (MCV), Mean erythrocyte hemoglobin (MCH), Reticulocytes, serum iron, and serum ferritin. Iron deficiency anemia if the level of hemoglobin \<11 g/dL, microcytic Hypochromia, serum ferritin \< 30 pg/dl, then given iron and vitamin D preparation for 4 weeks, then checked again complete blood count, serum fe and serum ferritin. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A P value \<0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Children's Iron deficiency anemia
2. Must be able to drink syrups

Exclusion Criteria:

1. Patients who have diarrhea
2. Patients who experience vomiting
3. Severe anemia
4. Post Transfusion
Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients

Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.

Healthy weight management and use of essential oils and aromatherapy as natural interventions to manage health-related issues are significantly growing interests. One frequent intervention for healthy weight management is bariatric surgery. In the post-operative period following bariatric surgery, nausea is a common consequence. Peppermint oil aromatherapy is an effective intervention for relieving nausea and other gastrointestinal symptoms in the bariatric and surgical population. This study has multiple aims. One is to determine effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population. A second aim is to establish relative cost-effectiveness of peppermint oil aromatherapy versus traditional anti-emetic drug therapies. A third is to determine whether peppermint oil aromatherapy increases patient satisfaction versus anti-emetic drug therapies. This is a randomized study with control and experimental groups. The control group will receive no peppermint oil aromatherapy and only traditional anti-emetics as needed. The experimental group will receive peppermint oil aromatherapy and traditional anti-emetics as needed.

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery candidate on 7-Lime at Lancaster General Hospital
* Scheduled for laparoscopic sleeve gastrectomy and laparoscopic Roux-En-Y (RNY) procedures
* Between ages of 18 and 70
* Surgical patient of either Dr. James Ku and Dr. Joseph McPhee

Exclusion Criteria:

* History of excessive sensitivity to peppermint oil, allergic response to peppermint oil and who state preference against aromatherapy
* Not alert and oriented or unable to follow directions will be excluded
* Severe reactive airway disease such as asthma or chronic obstructive pulmonary disease (COPD)
* Possible exclusion for severe hypertension or atrial fibrillation
A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants

This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers(Age: 19\~55 years, 65\~85 years)
2. Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²

Exclusion Criteria:

1. Clinically significant Medical History
2. Allergy or Drug hypersensitivity
3. AST, ALT, Total billurbin \> Upper Normal Range\*1.5, eGFR\<60mL/min/1.73m²
4. Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
5. Heavy smoker(more than 10 cigarettes/day)
6. Heavy caffeine intake(more than 5 units/day)
7. Heavy alcohol intake(more than 210g/week)
Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery

Primary objective of the study is the assessment of the patients' discomfort and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group (who will receive Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

1. Endothelial cell count less than 1900,
2. Glaucoma,
3. IOP-lowering medications,
4. Former incisional surgery,
5. Former diagnosis of corneal disease,
6. Diabetes or autoimmune diseases
7. Former diagnosis of dry eye disease
Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalation
* Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
* Biopsy accessible tumor (may be waived under certain circumstances)
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Infection
* Elevated triglycerides
* Gastrointestinal (GI) disease with increased risk of diarrhea \[e.g. inflammatory bowel disease (IBD)\]
* Taking medications known to increase risk of Torsades De Pointes
Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4

Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.

The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Women
* 40 years of age or more
* Symptomatic trapeziometacarpal osteoarthritis
* Eaton \& Glickel stage 4

Exclusion Criteria:

* An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
* Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
* Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
* Symptomatic carpal tunnel syndrome in same hand.
* Symptomatic Quervain's tenosynovitis in same hand.
* Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
* Insufficient knowledge of Dutch language.
Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

To determine the level of association between quantitative regional estimates of brain uptake of \[18F\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
* The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
* The subject's general health is adequate to undergo the study procedures.

Exclusion Criteria:

* The subject has a contraindication for PET.
* The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol or to any of the excipients.
* The subject is unable to tolerate or cooperate with study procedures.
Effect of Breather in COPD Patients with Intermittent Claudication

The aim of this study To show the effect of breather on ventilatory and vascular function in COPD patient with intermittent claudication.

recent researches show that COPD patients have risk of developing peripheral arterial disease (PAD) which represented on patient by intermittent claudication inspiratory muscle trainer as the breather device show increasing in inspiratory muscle strength and endurance; reduction of dyspnea; and improving of exercise tolerance .

Because of all this things this study tends to show the effect of the breather on ventilatory and vascular function in COPD patient with intermittent claudication.

Eligibility Criteria:
Inclusion Criteria:

* sixty male patients with diagnosed with grade I and grade II COPD their ages ranged between 55-60years
* All patients will be clinically and medically stable when attending the study.
* Body mass index (BMI) is 18.5 to 24.9 kg/m2.
* History of unilateral exertional leg pain,
* Ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage II of the fontaine classification of pad),
* And an ankle-brachial index (ABI) of 0.90 or lower at rest or 0.73 or lower after exercise.

Exclusion Criteria:

* cardiovascular insufficiency,
* Recent myocardial infarction,
* heart failure,
* arrhythmia,
* DVT,
* Intracranial hypertension,
* Pneumonia,
* kidney failure,
* fractures,
* uncooperative patients,
* cognitive impairment preventing a patient from participation in exercises.
Treatment of Moderate FMR During AVR

Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences).
2. Age more than 18 years.

Exclusion Criteria:

1. Those with a history of rheumatic valvular disease or infective endocarditis.
2. Primary mitral valve lesions.
3. Patients receiving mitral valve replacement.
4. Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery.
5. Age \< 18 years.
Surgical Treatment of Ischemic Mitral Regurgitation

The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent.
* Patients with a verified diagnosis of CAD, including post myocardial infarction scar.
* Coronary artery pathology to be coronary artery bypasses grafting.
* The presence of moderate or severe ischemic mitral regurgitation.

Exclusion Criteria:

* The patient did not sign the informed consent.
* Aortic valve disease requiring prosthetic or aortic valve repair.
* Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve).

  а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve
* Patients with acute coronary syndrome.
* The presence of the indications for angioplasty of the coronary arteries.
* Coronary artery bypasses grafting in history.
* Parallel patient participation in other studies.
* The organs diseases, which can be reason to death after surgery during the first 3 years.
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition

This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
2. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
2. Any condition possibly affecting drug absorption.
Photographic Rhinometry Following Derm/Mohs Surgery for Skin Cancers

Dermatological surgeons and patients routinely notice alterations in nasal shape and size following surgery and reconstruction. There is no uniform approach to objectively measure these changes. Anthropometric measurements are routinely used in rhinoplasty to assess outcomes, but they are time consuming and have not been reported as being used by dermatological surgeons. Soft-tissue measurements in profile photographs have been demonstrated to be useful for objective measurement of nasal change following surgery. This is a follow up study of the pilot study to assess the feasibility of photographic rhinometry as an objective tool, and (ii) to quantify changes following common dermatological surgical procedures on the nose. This follow-up study will aim to recruit a larger population sample to better quantify some of the changes occurring post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Male and female participants
* Type of cancer: Undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC))

Exclusion Criteria:

* Cases unable to consent to participation in the study
* Patients who are unable to complete the study assessments
* Patients below 18 years of age
* Patients undergoing surgery for other types of skin cancer
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study : 18 years to 74 years
* Genders eligible for study : Male and Female
* Diagnosed with T2DM
* Received diet and exercise therapy with or without metformin monotherapy
* HbA1c levels of between ≥ 7.0% and ≤ 10.0%
* Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
* Written informed consent must be obtained

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Diagnosis of type 1 diabetes mellitus
* Uncontrolled diabetes defined as a FPG level of \> 240 mg/dL
* A significant change in body weight in the 3 months before screening
* Any history of GI intolerance
* Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
* Known history of chronic pancreatitis
* A history of alcohol or drug abuse or drug addiction