cyrilzakka/clinical-trials huggingface dataset:
The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial

The hypothesis for this study is that oral Semaglutide, a GLP-1Ra, has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 50-85 years with type 2 diabetes and an increased risk of bone fractures. Treatment involves once daily oral GLP-1Ra semaglutide or matching placebo for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue and bone marrow tests (bone marrow aspiration and biopsy), physical activity assessed by a questionnaire, and direct bone strength measured by microindentation at the start and end of the study.


Eligibility Criteria:
Inclusion criteria

* Type 2 diabetes and glycosylated haemoglobin (HbA1C) of 48-91 mmol/mol (6.5-10.5%) and
* T-score \<-1 in hip or lower back, assessed by DXA scan and / or
* Low-energy fracture within the last 3 years

Exclusion criteria

* T-score \<-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they are not candidates for conventional osteoporosis therapy, e.g., due to allergies and renal impairment, or if they prefer to participate in the trial.
* Type 1 diabetes mellitus
* Severe NPDR (non-proliferative diabetic retinopathy) or PDR (proliferative diabetic retinopathy) assessed within the last year. If a recent assessment is unavailable, a new retinal photo test will be performed.
* Congestive heart failure (NYHA Class IV)
* Primary hyperparathyroidism
* Vitamin D deficiency (\<25 nM) (re-test after substitution acceptable)
* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \<30) or liver dysfunction (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease
* Clinically significant concomitant diseases or disorders (e.g., cancer) or clinically significant abnormal values in laboratory screening tests, including increased Choriogonadotropin (hCG) in women.
* History of gastrointestinal surgery (except uncomplicated surgical procedures such as hernia surgery and appendectomy)
* Antiresorptive or bone anabolic drugs for the last 12 months
* Use of anabolic steroids in the previous year
* Use of GLP-1Ras within 90 days
* Stable therapy with DPP4 inhibitors (unless the patient is willing to discontinue the treatment)
* History of pancreatitis
* Allergy or hypersensitivity to the active substance or to any of the ingredients
* Inability to give informed consent
* Previous bariatric surgery
* BMI \<20 kg/m2 or BMI\>37 kg/m2
Predicting Migraine Attacks Based on Environmental and Behavioral Changes as Detected From the Smartphone

This study is conducted at the Henry Ford Health System with Lifegraph's behavioral monitoring technology, to examine the relation between migraine attacks and behavioral and environmental changes as detected from the smartphone sensors. The investigators hypothesize that Lifegraph's technology can predict the occurrence of migraine attacks with high precision.

Migraine attacks can damage quality of life and lead to missed work days if not treated in time. These attacks last for about 4-72 hours, accompanied by headache and other symptoms. The time window for early intervention, which can potentially reduce the severity of an attack, lasts 2-48 hours before symptoms are starting to appear (10 hours on average). This time window is defined in the literature as the prodromal phase, when intervention during this phase can allow early treatment to improve the patient's condition and reduce the intensity and duration of the attack.

Migraine attacks and the prodromal phase can be characterized by one or more behavioral or environmental symptoms, either causal or resultant. Some of them can be passively measured by the smartphone usage, such as changes in sleep, physical activity and weather.

Lifegraph's smartphone application runs in the background of the subjects' personal smartphone, collects data passively and automatically, while rigorously maintaining privacy and with no effect to the daily use. Proprietary machine-learning algorithms analyze the collected data and turn it into behavioral channels, such as activity, sleep and mobility. The technology learns the personal routine of each user and detects changes in his/her behavioral patterns that can indicate an upcoming migraine.

Eligible subjects will meet a neurologist, sign an informed consent, fill an initial questionnaire and install the Lifegraph application on their smartphone. The application requires a one-time registration process.

During the study, subjects will self-report migraine attacks they experience through the smartphone application. Each report will include start time, end time and pain intensity. Data will be analyzed during the study in order to learn each subject's behavior and his/her migraine attacks. Subjects will be blinded to the app's migraine predictions to avoid expectancy bias.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who suffer from episodic migraine with 4-14 days of migraine per month (ICHD-3 patients).
* Individuals who possess a smartphone - Android version 5.0 and above or iOS version 10.0 and above.

Exclusion Criteria:

* Individuals who are unable to sign the consent form.
* Pregnant women.
* Individuals suffering from headaches that do not meet the IHS migraine criteria or don't have moderate to severe chronic pain of VAS chronic grade 4 and above.
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance

The purpose of this study are twofold:

1. To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation;
2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects: Subjects must be free from any acute, chronic or debilitating medical conditions. Healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph.

Exclusion Criteria:

* Any active acute or chronic medical problem: Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. The exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (CAD), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. Individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. In addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.
Levosimendan in Congenital Cardiac Surgery

Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support

Exclusion Criteria:

* Patients with renal and/or hepatic dysfunction
* Patients requiring inotropic support before their surgery
* Septic patients
Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery

The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.


Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing laparoscopic hysterectomy
* Age ranges 18-80
* Reading literacy
* English speaking
* Able to give informed consent

Exclusion Criteria:

* History of relevant drug allergy
* Chronic opioid users who may have tolerance to pain medications
* Inability to understand written consent forms or give consent
* Age less than 18 or over 80
* Any conversion to open surgery
Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme

This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. This study will use a new MRI technique to compare the images of blood vessels and tumor structure to the effectiveness of bevacizumab.

This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. Bevacizumab is a drug that your doctor believes is the best treatment option available to subjects at this time for this type of tumor. Bevacizumab affects the growth of blood vessels by tumors such as glioblastoma, thus effectively starving the tumor of oxygen and food.

Magnetic Resonance Imaging (MRI) is a test done by a machine in the radiology department that takes pictures of your body using special magnets, rather than X-rays. With a new MRI scan technique the investigators can take very, very detailed images of the vessel and tumor structure. This project will allow us to compare the images of vessel and tumor structure to the effectiveness of Bevacizumab as a treatment option. With this project the investigators will hopefully develop an accurate way to predict whether or not Bevacizumab will be an effective treatment option for patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years of age
* Progressive glioblastoma patients who have been planned to receive bevacizumab
* Karnofsky Performance Status 50 or above (vd. Appendix A)
* Established pathologic diagnosis of glioblastoma
* Prior treatment with radiation and chemotherapy
* Neuroimaging progression of glioblastoma
* Able and willing to provide informed consent (or consent of a guardian)

Exclusion Criteria:

* Contraindication to MRI
* Contraindication to bevacizumab therapy
* Concurrent enrollment in other neuroimaging trials
* Prior therapy with bevacizumab
* Known hypersensitivity to MRI contrast
* Females who are nursing or pregnant
Study of AO-176 as Monotherapy and in Combination With Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics and initial efficacy of AO-176 as monotherapy and in combination with dexamethasone and bortezomib in adults with relapsed/refractory multiple myeloma (MM).

An open-label, multicenter, dose escalation study to evaluate the safety, tolerability and PK/pharmacodynamics of AO-176 in adults with relapsed/refractory multiple myeloma whose disease has progressed following at least 3 prior systemic lines of treatment and must have progressed on the final line of therapy received before being considered for this study.

The study will be conducted in 2 phases; Phase 1 is an ascending-dose study of AO-176 monotherapy utilizing the classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a dose-limiting toxicity (DLT). Following the dose escalation portion and determination of the monotherapy recommended phase 2 dose (RP2D), an ascending dose escalation study of AO-176 and dexamethasone combined with bortezomib will be evaluated utilizing the same 3+3 dose escalation design.

Phase 2 will evaluate the clinical activity of AO-176 plus dexamethasone and bortezomib at the RP2D as determined in Phase 1 Part 2.

Eligibility Criteria:
Key Inclusion Criteria:

1. Confirmed diagnosis of symptomatic MM per IMWG criteria
2. Measurable disease
3. Relapsed or refractory to at least 3 prior systemic lines of therapy for MM
4. Eastern Cooperative Oncology Group (ECOG) status 0-2
5. Resolution of prior therapy-related adverse events
6. Minimum of 2 weeks since last dose of cancer therapy or radiotherapy

Key Exclusion Criteria:

1. Previous Grade 3-4 infusion or hypersensitivity reaction
2. Severe asthma or chronic obstructive pulmonary disease exacerbations requiring hospital admission or steroids
3. Prior treatment with a checkpoint inhibitor (anti-PD-1, PD-L1 or CTLA-4) within 4 weeks.
4. Prior treatment with a therapeutic agent that targets the CD47 axis.
Palmitoylethanolamide for Post-operative Pain Prevention

Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries.

Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events.

The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective gynecological or urological surgical procedures

Exclusion Criteria:

* age \< 18
* pregnancy or nursing
* pre-existing chronic pain
* severe hepatic or renal failure
* post-operative progression of local cancer disease
* post-operative infection or inflammation of surgical wound
Neurologic and Immunologic Characteristics of CTLA-4 and LRBA Hereditary Deficiency

CTLA4 and LRBA deficiencies are rare genetic disorders, recently described, and associated with multiple clinical features. It ranges from recurrent infections, auto-immunity, and organ infiltration with lymphocytes. Neurologic syndroms are described in up to 30% of patients, yet they are poorly defined to date. Early recognition of a specific pattern can be important, given that there is a targeted therapy in this situation.


Eligibility Criteria:
Inclusion criteria:

- Patients diagnosed with CTLA4 or LRBA mutation

Exclusion criteria:

- Age \< 12 years
Exercise and Respiratory Training as Supportive Treatments for Patients With Chronic Pulmonary Hypertension

Background

-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.

Methods

-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.

Prospects

-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe chronic PH who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate.

Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.

Exclusion Criteria:

* Patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.
Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance

This study investigates the influence of a remote, painful stimulus on stretch tolerance. Half of the participants will receive a conditioning painful stimulus following static stretching while the other half will rest quietly.

The effect of stretching on joint range of motion is primarily related to changes in the tolerance to stretch, but the mechanisms underlying this change are still largely unknown.

The nervous system has an inbuilt ability to modulate the perceived magnitude of afferent noxious stimuli via supraspinally mediated endogenous pain inhibition or facilitation and by engaging endogenous mechanisms pain tolerance in healthy individuals is known to increase. Thus increasing the tolerance to pain could potentially increase range of motion following stretching.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.

Exclusion Criteria:

* Substance abuse,
* History of neurological or mental disabilities
* Lack of ability to comply with instructions
* Delayed onset of muscle soreness.
A Non-invasive Evaluation of Kidney-Lung Interactions

The present study aims to evaluate, with non-invasive methods, the relationships existing between PEEP and renal perfusion in patients undergoing surgery and requiring ventilatory support and monitoring in intensive care. Renal perfusion will be assessed at baseline (PEEP 0), subsequently ,at the application of progressive increases of PEEP. At the end of the measurements, the implications of the use of PEEP on the renal vascular system will be analyzed.

The present physiological, monocentric, observational clinical study evaluates the effect of progressive PEEP increases on renal perfusion in mechanically ventilated patients who underwent surgery with the need of ventilatory support and monitoring in intensive care.

Precisely, will be evaluated:

* The morphometric parameters (coronal diameter and cortico-medullary thickness) and the renal resistive indices (IR). The inter-lobar arteries will be sampled and the IRs will be measured as the upper and lower level and the mesorenes. Measurements will be performed both in the kidney and in baseline conditions and incremental values of PEEP (0 - 6 - 12).
* Gas exchanges, FC, systolic BP, diastolic and mean, Pmax, P1 and P2 of the airways, total and ohmic resistances and static respiratory compliance indexed for weight body (RRSmaxI, RRSminI, CrsI will be recorded).

The intra-class correlation coefficient will be measured to estimate the intra-observer reproducibility of the conducted measurement.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Receiving mechanical ventilation, invasive blood pressure monitoring and an urinary catheter to monitor diuresis
* Need for postoperative monitoring in intensive care
* Written informed consent;

Exclusion Criteria:

* Acute kidney injury defined according to KDIGO guidelines;
* Pre-existing chronic renal disease;
* Heart failure;
* ARDS;
* Sepsis and Septic Shock;
* Hemodynamic instability with the need for vasoactive support;
* Chronic or occasional therapy with drugs that could modify the renal blood flow and that can not be suspended two days before the study (Vasoactive agents, Ace-inhibitors, Beta-blockers, NSAIDs, Sartans and Diuretics therapy);
* Presumed or established state of pregnancy;
* Refusal of informed consent;
Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.

Eligibility Criteria:
Inclusion Criteria:

* 60 to 85 years of age
* Having at least one modifiable dementia risk factor
* Complaints of cognitive decline by a participant or informant
* A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
* MMSE Z score ≥ - 1.5
* Independent activities of daily living
* Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
* Having a reliable informant who could provide investigators with the requested information
* Provide written informed consent

Exclusion Criteria:

* Major psychiatric illness such as major depressive disorders
* Dementia
* Other neurodegenerative disease (e.g., Parkinson's disease)
* Malignancy within 5 years
* Cardiac stent or revascularization within 1 year
* Serious or unstable symptomatic cardiovascular disease
* Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
* Severe loss of vision, hearing, or communicative disability
* Any conditions preventing cooperation as judged by the study physician
* Significant laboratory abnormality that may result in cognitive impairment
* Illiteracy
* Unable to participate in exercise program safely
* Coincident participation in any other intervention trial
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A healthy adults aged 19-50 years

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* Hypersensitivity to ingredient of IP and other medication, food
* Participation in any other study within 3months
* History of whole blood donation within 2months and Apheresis 1month