cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (i e, women not of childbearing potential) participants
* Body Mass Index (BMI) of 18 to 32 kg\^m2 and total body weight ≥ 50 kg
* Parts A, B, and D: Participants without restriction on ethnicity
* Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)

Exclusion Criteria:

* Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
* Any major surgery within 3 months of study intervention administration
* Participation in another clinical trial concurrent with this study

Note: Other protocol-defined inclusion/exclusion criteria apply
Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke

Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.

As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.

Eligibility Criteria:
Inclusion Criteria:

* According with the stroke diagnosis of Traditional Chinese Medicine
* According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations
* It has attacked in 7 days
* The assessment of scale of NIHSS:4-24 points
* Age: ≥ 35 years and ≤ 75 years
* Patients or their legal guardians sign informed consent form

Exclusion Criteria:

* The patients with ICH or cerebral hemorrhage or TIA
* It has attacked beyond 7 days
* Patients with stroke history and the mRS ≥ 2 points before this attack
* Mixed type of stroke (infarction after bleeding or bleeding after infarction)
* Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating
* Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding
* Women of pregnancy or breast-feeding
* Patients who are taking part in other clinical trials that will influence the results of this study
A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD).

Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥18 years
2. Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
3. Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol

   .
4. Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening:

   1. Liver stiffness through transient elastography, an LSM ≥8 kPa OR
   2. Serum ALT ≥45 U/L

Exclusion Criteria:

1. Consumption of alcohol for at least 90 consecutive days in last one year: \>2 units of alcohol per day (\>14 units per week) for males and \>1 unit of alcohol per day (\>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor
2. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
3. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
4. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
5. History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
6. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
8. Pregnant or breast feeding females
Magnesium Sulphate and Rocuronium in Patients Over 60

The purpose of this study is to evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.


Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* ASA physical status I-III
* Scheduled for elective oncologic head and neck surgery

Exclusion Criteria:

* Severe renal insufficiency (calculated creatinine clearance \< 30 ml/min)
* Pre-operatory serum magnesium values \> 2.5 mEq/l
* Patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)
Choline Quantification in Breast Cancer by MRS

Choline has been found in increased concentration in breast cancer patients. Hypothesis: The choline signal as observed by MRS is sensitive to treatment, and a positive response to treatment will give a reduction in choline concentration.

The purpose of this study is to establish methods for quantification of choline in breast cancer by MRS

1. Establishment of new MRS sequence for choline quantification of choline. This sequence is choline-selective, and signals from water and lipids are suppressed simultaneously.
2. Compare to different methods for choline quantification. The first method is quantification through an external phantom standard, containing a known concentration of choline. The other method is based on the utilisation of internal water signal as a reference.

Both calculations can be performed from the same MR exam. Ten patients will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer

Exclusion Criteria:

-
B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors

We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and 2) we will study in post-menopausal women (target group) the biological effect (bioefficacy) associated with the regular consumption of modified milk-based fruit beverages (containing b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone turnover and cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women, 45-60 years old

Exclusion Criteria:

* Dieting
* Food allergy (to any components provided)
* Hormone replacement therapy
* Cholesterol lowering drugs, antiresorptive or anabolic bone drugs
* Calcium and vitamin D supplements
* Soybean products
* Vitamin-mineral supplements
* Fibre supplements
* Commercially available enriched foods (i.e. w-3, phytosterols,carotenoids,...)
Correspondence of ScO2 and Cardiac Output in Hemodialysis

The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared.


Eligibility Criteria:
Inclusion Criteria:

Ambulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology.

Exclusion Criteria:

Age below 18 years. Failure to give informed consent.
Measurement Properties of the Turkish Version of the Low Back Pain Knowledge Questionnaire

This study aims to assess the validity and reliability of the Turkish version of the Low Back Pain Knowledge Questionnaire (LKQ). This questionnaire is a comprehensive, disease-specific tool that evaluates knowledge about low back pain. Adapting it into Turkish will provide healthcare professionals with a valuable resource for assessing patient awareness, guiding educational programs, and improving clinical practices for low back pain management.

This study aims to evaluate the validity and reliability of the Turkish version of the Low Back Pain Knowledge Questionnaire (LKQ), a comprehensive tool that assesses individuals' knowledge about the characteristics, symptoms, causes, and management of low back pain. The study will follow a systematic process, including translation, cultural adaptation, and psychometric evaluation. After translating the questionnaire using the forward-backward method, a panel of experts will review it for clarity and cultural relevance. The adapted questionnaire will be tested on a diverse sample to assess internal consistency (Cronbach's alpha) and test-retest reliability. The results will provide a validated Turkish version of the LKQ, enabling healthcare professionals to assess patient knowledge, guide educational programs, and improve low back pain management and prevention strategies.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or over
* Turkish as their mother tongue
* Presence of back pain of any duration
* Volunteered to participate in the study

Exclusion Criteria:

* Failure to complete the questionnaire
Brady MX a Quality Improvement Study

Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years of age
* Patient´s heart rate meets at least one of the following:

Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance

* Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia)
* Patient (or patient´s legally authorized representative) is willing and able to sign and date written Patient Consent Form/Data Release Form

Exclusion Criteria:

* Patient has recent history of blood loss
* Patient has a medical history leading to suspicion of neurological disorder
* Patient has a history of Chronic Atrial Fibrilation
* Patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from Medtronic study manager
* Patient is not expected to survive 12 months
* Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
Analysis of Stroke Rehabilitation Outcomes

Observe and describe the relationships between impairments and function, systematically characterize recovery patterns and examine short and long term rehabilitation outcomes. This project is purely observational, descriptive and non-experimental. N=273

This project involves an interdisciplinary stroke database of demographic variables and clinical measures collected during routine acute care, inpatient rehabilitation admission and discharge as well as follow up questionnaires at 6 month and 12 months to examine stroke recovery.

Our aim is to observe and describe the relationships between impairments and function, systematically characterize recovery patterns and examine short and long term rehabilitation outcomes.

This project is purely observational, descriptive and non experimental. No rehabilitation interventions or treatment procedures are being introduced, modified or studied.

Eligibility Criteria:
Inclusion Criteria:

Patients who have a confirmed primary diagnosis of cerebrovascular accident (CVA) as per radiological assessment, met the criteria to be admitted onto Baker 17 (the New York Presbyterian inpatient rehabilitation unit), and were administered standardized assessments or rating scales as part of routine standard care will be included in the database.

Exclusion Criteria:

Persons with stroke who could not be given standard assessments or rating scales (eg.

due to fatigue, decreased attention span, global aphasia or refusal) will not be included in data analysis.
Endovenous Versus Liposomal Iron in CKD

Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Signed written informed consent;
* Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
* hemoglobin ≤ 12g/dL;
* Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
* If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;

Exclusion Criteria:

* Infectious diseases;
* bleeding in the preceding six months;
* History of malignancy tumor in the last 3 years;
* Anemia case different from that resulting from CKD;
* vitamin B12 and folate deficiency;
* Surgery of any kind in the last three months;
* systemic haematological disease;
* Blood Transfusions, therapy with intravenous or oral iron in the last three months;
* Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);
* Abuse of alcohol and drugs in the preceding six months;
* immunosuppressive therapy ;
* Significant weight loss;
* Pregnancy or breast-feeding.
A Proof of Concept Study of Pan-cancer Early Detection by Liquid Biopsy

PROMISE is a multi-center, prospective and proof of concept study aimed to evaluate the performance of 3 prototype assays of cell-free DNA (cfDNA) mutation, cfDNA methylation and microRNA (miRNA) expression in early detection of multi-cancer. Assay(s) will be selected for further development. The study will enroll approximately 2035 participants, including participants with cancers and healthy participants.

Blood samples will be prospectively collected from cancer patients and non-cancer individuals. Targeted cell-free DNA (cfDNA) methylation panel of \~490,000 CpG sites, a 168-gene mutation panel and 16 proteins will be applied. Participants will be stratified by age and clinical status and split into the training and the testing sets. The multi-cancer detection blood test models were developed on training set and validated on testing set.

Eligibility Criteria:
Inclusion Criteria for Cancer Arm Participants:

* Ability to provide a written informed consent
* 40-75 years old
* Ability to comply with study procedures
* Confirmed diagnosis or suspicious cases of one of the 9 types of cancers within 42 days prior to study blood draw.
* No prior anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
* Known prior diagnosis of malignancies, other current malignant diseases or multiple primary tumors
* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease or precancerous lesions by histopathological assessments, or inability to characterize whether the lesion is malignant or benign

Inclusion Criteria for Healthy Arm Participants:

* Ability to provide a written informed consent
* 40-75 years old
* No cancer-related symptoms or discomfort within 30 days prior to study blood draw
* Ability to comply with study procedures
* No clinically significant finding by laboratory tests and radiology examinations

Exclusion Criteria for Healthy Arm Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Clinically significant or uncontrolled comorbidities
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report

A spirometry study is performed in a patient diagnosed with allergic bronchopulmonary aspergillosis. An initial measurement is carried out and the patient is then put on a four-week physiotherapy treatment plan. Four spirometry measurements were taken to assess different variables and an improvement in all the spirometry values was established.


Eligibility Criteria:
Inclusion Criteria:

* woman
* diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis
* over 50 years of age
* under 80 years of age

Exclusion Criteria:

* male
* not have a diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis
* under 50 years of age
* over 80 years of age
Music for Pain in the Waiting Room

This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of two, 4-minute, audio-recorded, music interventions (one with lyrics and the other without) for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by research staff to interfere with study involvement.
The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty

This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone.

Effective postoperative pain control in hip surgeries can reduce complications and improve postoperative care. Multimodal analgesic techniques in postoperative pain management are employed to synergistically target different nociceptive mechanisms. Combining peripheral nerve blocks with low-dose intrathecal opioids can decrease the systemic opioid dose. Additionally, side effects associated with opioids, such as sedation, respiratory depression, nausea, vomiting, rash, and urinary retention, can be mitigated by the combination with peripheral nerve blocks.

The addition of Pericapsular Nerve Group (PENG) block to a multimodal analgesia regimen has been shown to significantly enhance the quality of recovery and reduce opioid consumption in patients undergoing hip arthroplasty.

The Quality of Recovery (QoR-15), developed and validated by Stark et al. in 2013, is a recovery scale indicating postoperative recovery quality. It includes 15 questions assessing pain, physical comfort, physical independence, psychological support, and emotional state, providing a score between 0 and 150, where a higher score indicates better recovery quality.

In anterior hip surgeries, it is anticipated that spinal anesthesia combined with PENG block and low-dose intrathecal morphine will result in lower postoperative morphine consumption and pain scores compared to PENG alone and intrathecal morphine alone over the first 48 hours. Furthermore, it is expected that the quality of recovery (QoR-15 score) will be higher, providing patients with a longer pain-free period, early mobilization, and improved recovery quality.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 90 years
* American Society of Anesthesiologists (score ranging from 1 to 4)
* Anterior hip arthroplasties

Exclusion Criteria:

* Patients with a history of opioid addiction
* Individuals under the age of 18
* Those aged 90 and above
* Allergies to morphine, fentanyl, bupivacaine, or tramadol
* Coagulopathy
* Infection at the injection site
* Severe cardiac, renal, or hepatic dysfunction
* Cases unable to provide informed consent
* Body Mass Index \>40 kg/m2
* Known neurological or anatomical deficits in the lower extremities
* Patients requiring a transition from spinal anesthesia to general anesthesia