cyrilzakka/clinical-trials huggingface dataset:
A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.


Eligibility Criteria:
Inclusion Criteria:

Participants

* are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \[EHR\] is required prior to screening)
* have a Telephone Interview for Cognitive Status (TICS) score of ≥21
* presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \[CSF\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)
* have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and
* have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study.

Exclusion Criteria:

* have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)
* have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (\>12 months) institutional-level care, serious psychiatric illness, etc.)
* are currently enrolled or intend to enroll in a clinical trial of another investigational product, and
* have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).
Comparative Study to Evaluate the Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca Compartment (FIC) Block on the Postoperative Analgesic Effect in Patients Undergoing Hip Surgeries Under Spinal Anesthesia.

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.


Eligibility Criteria:
Inclusion Criteria:

* Forty -Two patients above 18 years of age belonging to the American Society of Anaesthesiologists (ASA) physical status Classes I and II scheduled for hip surgery will randomly be allocated into two groups. Group A (PENG block) will receive US - guided PENG block and Group B (FIC block) will receive US - guided FIC block for postoperative pain relief.

Exclusion Criteria:

* Patient refusal.
* Patient with significant neurological, psychiatric or neuromuscular disease.
* Alcoholism.
* Drug abuse.
* Pregnancy or lactating women.
* Suspected Coagulopathy.
* Morbid obesity.
* Known allergy to study medications.
* Septicemia and local infection at the block site.
Dry Needling and Maitland Joint Mobilization Techniques in Patients With Myofacial Chronic Neck Pain

The purpose of my research is to compare the effects of dry needling and Maitland mobilization in chronic myofacial neck pain

To distinguish which technique is most effective in pain reduction and range gain because in chronic cases there is involvement of fascia, muscles and joints due to prolonged stress on any of the component affecting the other. Hence, the study will help to design a treatment plan with more accurate intervention. After sample collection according to selection criteria treatment sessions will be given to both groups for 6 weeks. Data will be collected at baseline, then after 2 weeks, 4 weeks and at 8th week. Tools for data collection are Visual analogue scale, Neck Disability Index and Goniometer. For statistical analysis SPSS 22 will be used. Intra group difference will be calculated by repeated measurement ANOVA / Friedman test and inter group analysis will be done by Independent sample t test. Descriptive data will be expressed in terms of frequency and proportions.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral pain involving the upper trapezius and elevator muscle of the scapula;
* Duration of pain of at least 3 months;
* A pain intensity corresponding to at least 20 mm on a 100 mm visual analogue scale (VAS)
* Neck pain with symptoms provoked by either neck postures or neck movement;
* Pain localized at least in the cervical and occipital regions but not in the orofacial region;
* Neck disability index (NDI) greater than or equal to 15 points;
* Restricted cervical range of movements (flexion, extension, rotation, and sidebending); (i) Presence of bilateral MTrPs in upper trapezius and levator scapulae muscles

Exclusion Criteria:

* Any signs, symptoms, or history of the following diseases:
* Orofacial pain and temporo-mandibular disorders
* A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);
* Systemic diseases such as fibromyalgia, systemic erythematous lupus, and arthritis; (d) Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);
* Concomitant medical diagnosis of any primary headache (tension type or migraine);
* Unilateral neck pain;
* Cervical spine surgery;
* Clinical diagnosis of cervical radiculopathy or myelopathy;
* Needle phobia;
* History of previous physical therapy intervention for the cervical region in last 6 months.
Combined General and Spinal Anesthesia Compared to General Anesthesia During Laparoscopic Surgery : a Randomised Controlled Trial

The goal of this clinical trial is to learn if combining spinal and general anesthesia is better than general anesthesia alone for abdominal laparoscopic surgery in adults. The main questions it aims to answer are:

Does combining spinal and general anesthesia provide better stability compared to general anesthesia alone during abdominal laparoscopic surgery? Does combining spinal and general anesthesia lead to less opioid consumption compared to general anesthesia alone for abdominal laparoscopic surgery?

Participants will:

Be randomized and allocated to either spinal and general anesthesia (combined) group vs general anesthesia (control) group In the combined group, participants will be given a spinal anesthesia followed by general anesthesia, compared to general anesthesia alone in the control group.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) 1-2
* BMI ≤ 30 kg/m2
* Adults (18-64 years old) who will undergo elective abdominal laparoscopic surgery (digestive surgery, gynecologic surgery or urologic surgery)
* Willing to participate in this study

Exclusion Criteria:

* Cardiovascular disease (uncontrolled stage 2 hypertension, AV block, valvular heart disease, heart failure or arrythmia)
* Cerebrovascular disease (within \< 3 months)
* Infection at the proposed site of spinal injection
* Coagulopathy
* Elevated intracranial pressure
* Severe kidney or liver dysfunction

Drop out criteria:

* Anesthesia duration \> 6 hours
* Intraoperative emergency
* Conversion to open laparotomy
* Spinal complications (shock, anaphylaxis, seizure or high spinal)
* Failed spinal (2 attempts)
Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

Clinical and Radiographic Evaluation of the Effect of Hyaluronic Acid Surface Treatment Versus Sandblasted Acid Etched on Stability of Delayed Dental Implant in Posterior Maxilla.

A dental implant is one of the procedures to restore missing teeth , to achieved the stability for implant success is the direct growth of bone to the implant surface, known as Osseointegration.As a result, bone stability around dental implants is determined by factors that the implantologist may or may not directly influence, such as local bone quality and bone metabolism, as well as systemic factors such as age, systematic chronic diseases and lifestyle (e.g., smoking habits).Treatment-related factors include augmentation material, implant design (macro and micro), surgical procedures, and loading protocols. Therefore , it may be needed for a surface treatment could alter the topography, chemical content, and roughness of the surface and result in various biological reactions. The surface treatment can also increase the area of contact between the implant and the supporting bone . The rationale is evaluate Increasing the implant stability around implants placed by using hyaluronic acid that act to improving the connection between implant and bone .Sandblasting and acid etching is the most commonly used basic method for modifying the surface of dental implants . the sandblasting procedure "roughs up" the outer layer of the implant,creating a surface that is easier for the bone to grip as the implant heals.While hyaluronic acid and its derivatives have a strong chance of osseointegration and mineralization and have been utilized extensively for bone repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients with missing teeth in posterior maxilla.
* Both genders males and females will be included.
* Age from 18-60 years.

Exclusion Criteria:

* General contraindications to implant surgery.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.


Eligibility Criteria:
Inclusion Criteria:

Signed informed consent

* Age ≥ 18 years
* Subjects eligible for SCT
* Subjects having the disease MDS, mixed myelodysplastic/myeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts
* All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study

Exclusion Criteria:

* No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis
* Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders
* Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures

The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.

This study aimed to evaluate the prevalence of vertebral fractures in a cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.It is estimated that 250 patients will be enrolled (Patients will be enrolled in retrospective and prospective way between 01/03/2025 and 28/02/2026. The presence of one or more vertebral fractures will be evaluated through the radiological medical assessment with automatic 3D reconstruction of the thoracic and lumbar spine and by application of the AI software NanoxAIHealthVCF NANO-X IMAGING LTD on abdomen-chest CT studies.

Clinical, anthropometric, and anamnestic data will be collected from patients undergoing CT assessments. These data will be collected on the day of the radiological examination.

There will be only one evaluation at the time of the CT scan. Only in case of fracture detection, via radiological medical assessment and/or via AI software, the patient will be subsequently evaluated in the Endocrinology Unit as for standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects
2. Age ≥ 50 years
3. Clinical and medical history data available at abdomen-chest CT evaluation
4. Signature of informed consent to the study

Exclusion Criteria:

1. Hospitalized patients
2. Patients known to have osteo-metabolic diseases.
3. with primary and/or acquired immunodeficiency states, and/or severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacute/compensated chronic diseases; moderate-severe renal failure)
4. Patients unable to understand and sign the Informed Consent.
Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies

This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to, the following:

1. Confirmed diagnosis of solid tumor malignancy
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
3. Adequate hepatic, renal and bone marrow function
4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1

Exclusion Criteria:

Exclusion criteria include, but are not limited to, the following:

1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
3. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months
5. Patients with serious non healing wound or acute ulcer
6. Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months
7. Patients with history of abdominal or tracheal-esophageal fistula
8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
9. Prior treatment with bevacizumab within last 6 weeks
10. Pregnant or breast-feeding women
Oral Melatonin Plus Zinc Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

The purpose of this study is to evaluate the effects of oral melatonin plus zinc supplementation in relieving self-reported fatigue in CFS/ME

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is a complex medical condition, characterized by severe disabling fatigue with no known cause, no established diagnostic tests, and no universally effective treatment. No studies have evaluated symptomatic treatment using oral melatonin plus zinc supplementation in CFS/ME. The primary endpoint was to assess the effect of melatonin plus zinc supplementation on self-reported fatigue. Secondary measures included self-reported outcomes of sleep problems, anxiety/depression, dysautonomia, QoL and side-effects during treatment.

Eligibility Criteria:
Inclusion Criteria:

* CFS patient based on the 1994 Centers for Disease Control and Prevention/Fukuda definition.
* Patient who provided signed informed consent.

Exclusion Criteria:

* Patients who are participating in another clinical trial of the same or different nature previous 30 days prior to inclusion.
* Any subject that, in the judgment of the investigator, is not able to follow the instructions or to perform a good completion of the treatment.
* Subjects that do not provide signed informed consent.
* Patients who are receiving any of the drugs or products that may interfere with the results, and whose withdrawal could be a relevant medical problem.
* Patients receiving oral anticoagulants.
* Pregnancy or lactation
* Patients with hypersensitivity to melatonin and/or zinc.
A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan

The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female between 20 and 70 years of age
* Good general health as determined by physical examination, laboratory screening, and review of medical history
* Available for the duration of the study
* Willingness to sign the informed consent document
* Female of childbearing potential willing to use effective contraception for the duration of the trial

Exclusion Criteria:

* Females currently pregnant, as determined by positive β- human choriogonadotropin (HCG) test, and/or breast-feeding.
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
* Behavioral, cognitive, or psychiatric disease
* Below lower limit of normal for absolute neutrophil count
* Any significant alcohol or drug abuse in the past 12 months
* History of a severe allergic reaction or anaphylaxis
* Self-reported systemic hypersensitivity to any of the vaccine components
* Severe asthma
* Known HIV, Hepatitis B or hepatitis C
* Any known immunodeficiency syndrome
* Use of anticoagulant medications
* Receive chronic administration of immunosuppressant drugs within 6 months prior to the administration of the study vaccine
* Use of any investigational product within 30 days before study vaccination or at any time during the study
* Asplenia
* Receive administration of immunoglobulins and/or any blood products within 12 months preceding the administration of the study vaccine or at any time during the study
* Fever or suspected fever within 72 hours prior to vaccination or tympanic temperature greater than 38°C on the day of vaccination
* Receive administration of any licensed live attenuated vaccines within 30 days preceding the administration of the study vaccine and ending 30 days after
* Receive administration of any licensed inactivated vaccines within 14 days preceding the administration of the study vaccine and ending 14 days after
* Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects

The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is common in hospitalized patients, especially in the elderly with coronary artery disease (CAD) and/or those with chronic heart failure. Hypomagnesemia is associated with increased incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function, including platelet aggregation and adhesion. The data regarding the absorption difference between supplemental magnesium oxide and magnesium citrate in humans is spare.

Two oral preparations of magnesium are available in Israel:

1. Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
2. Magnox 520 TM (magnesium oxide, 520 mg elemental magnesium), Naveh Pharma Ltd., Israel.

The data regarding the absorption difference between the two supplemental magnesium preparations (magnesium oxide and magnesium citrate) in humans is spare.

Primary objective: To find out the absorption of magnesium citrate compared to magnesium oxide in healthy subjects with no apparent heart disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-70 years
2. Healthy subjects

Exclusion Criteria:

1. Chest pain
2. Diabetes mellitus
3. Documented coronary artery disease
4. Asthma or any lung disease
5. Chronic diarrhea
6. Chronic renal failure (serum creatinine\> 3 mg/dL)
7. Hypo or hyperthyroidism
8. Heart failure
9. On any chronic therapy/medications
10. Malabsorption
11. AV block
12. Pacemaker
13. Any malignancy
14. Obesity \> 30 kg/m2 body mass index
15. Smokers
16. Pregnancy
17. Alcohol or drug abuse
18. Any chronic inflammation
19. Refuse to sign inform consent
A Study of LY2801653 in Healthy Participants

This type of study is called a radiolabeled study. For this study, LY2801653 (study drug) has been specially prepared to contain radiolabeled carbon \[\^14C\]. \[\^14C\] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy people. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy sterile male and female participants
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2), inclusive

Exclusion Criteria:

* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study
* Have donated blood of more than 500 milliliter (mL) within the last month
* Have participated in a \[14C\]-study within the last 6 months prior to admission for this study
* Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
* Have a defecation pattern less than once per 2 days or acute constipation within 3 weeks of day before dosing