cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Intervention in Obese Non-diabetic Adults With a Family History of Diabetes.

The aim of this study is to investigate weather gradual weight loss achieved with healthy lifestyle changes influence hormonal factors affecting appetite and blood glucose control in obese people without presence of diabetes.

Obesity is becoming a growing and significant public health problem. Evidence from various national surveys over the last 25 years show that the prevalence of obesity and overweight in adults in England has increased threefold. There is still no clear evidence available to explain the epidemic levels of obesity. A number of neuro-endocrine factors have a role in the regulation of food intake and in the control of insulin secretion. We are particularly interested in measuring levels of a hormone called Glucagon-like peptide 1 (GLP-1) which is released from the intestine when food is absorbed. This hormone in turn has an influence on the production of insulin and another hormone, glucagons, both of which are involved in controlling blood glucose ('blood sugar') levels and appetite control.

There is some evidence, that obese people with normal blood sugar control show attenuated GLP-1 levels, however the evidence is contradictive and statistical significance is unclear. There is an ample of evidence that in established diabetes GLP-1 levels are attenuated, however it still remains uncertain whether the lower GLP-1 levels contribute to the pathogenesis of the condition or are a consequence of chronic hyperglycaemia or other hormonal and metabolic changes, though the observation that GLP-1 levels are lower in obese subjects suggests the possibility that the former may be the case.

Recently Bournemouth Diabetes and Emdocrine Centre (BDEC) conducted a research trial on effect of weight loss on GLP-1 levels in subjects with new onset type 2 diabetes. After 8 months intensive lifestyle programme average weight loss was 7.8 kg with significant and sustained improvements in clinical and metabolic parameters. Despite this, the GLP-1 levels remained unchanged.

None of the previous studies looked how gradual healthy lifestyle changes with sensible weight loss goals and increased activity levels effect GLP-1 levels in obese non-diabetic population.

Eligibility Criteria:
Inclusion criteria:

1. BMI between 30-39.9kg/m2
2. Family history of diabetes (self reported)
3. Normal and impaired glucose tolerance
4. Obtain informed consent

Exclusion criteria:

1. BMI less than 30kg/m2 or more than 39.9kg/m2
2. Presence of diabetes or any other chronic disease or disability that might interfere with the study results
3. Anti-obesity or any other prescription medications that may interfere with the study results
4. Pregnancy
5. Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting
6. Attending another weight management programme
7. Patients who would be unable to attend at least 75% of the programme sessions for medical or other reasons
8. Unable to provide informed consent.
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.


Eligibility Criteria:
Inclusion Criteria:

* Subject is between the ages of 18 and 75.
* Subject has a confirmed adenocarcinoma by histology of the prostate.
* Subject has CAPRA \> 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases
* Subject is scheduled to undergo robotic prostatectomy with extended pelvic lymph node dissection (ePLND) using an da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.
* Subject is willing and able to provide informed consent
* Subject is considered capable of complying with study procedures and of understanding a written informed consent document.
* Subject must be treatment naïve (not having received neo-adjuvant therapy, radiation therapy, hormonal therapy, androgen deprivation therapy within the last 4 months excluding Finasteride, Dutasteride, or other 5 alpha reductase inhibitors, or focal ablation techniques)

Exclusion Criteria:

* Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Subject is currently participating in and receiving study therapy or has participated in a study of an investigational agent within the past 6 months; is receiving study therapy or is involved in a significant risk investigational device study within the past 6 months
* Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
* Subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy
* Subject has a known history of acute or chronic liver or kidney disease
Dijon Stroke Cohort

The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic attacks (TIAs) within the city of Dijon since 1985.

As a result of the development of therapies for acute disease, the prognosis of patients has improved over time. Thus, the number of stroke survivors has increased by 90% between the 1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and functional impact of stroke for motor, cognitive or thymic function. In the absence of available data in France, the investigators wish to set up an extended cohort follow-up of patients in order to study their long-term prognosis and to study the impact of future therapies on the evolutionary course of the disease.


Eligibility Criteria:
Inclusion Criteria:

* patients included in the Dijon Stroke Registry and not opposed to participating

Exclusion Criteria:

* minor patients; opposition to participation
Measuring Daily Grain Intake Study

The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.

The aim of this study is to identify compounds that are found in blood and urine and are derived from repeated daily consumption of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 - 75 years
* non smokers

Exclusion Criteria:

* Body weight less than 110 lbs.
* Have a body mass index below 19 or above 38 kg/m2
* Known (self-reported) allergy or adverse reaction to study foods
* Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
* History of certain cancer diagnosis or treatment in the last 3 years
* Smoking or use of tobacco products in the past 6 months
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Analysis of Lipids in Human Milk At Different Gestational Ages

Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.

Mother's milk is the best food for the newborn as it is the only one capable of providing species-specific nutrition, guaranteeing everything necessary for the growth and maturation of a child. Mother's milk has the property of satisfying metabolic needs by changes in the composition of nutrients, which are different at each stage of life. Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The metabolomic study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk is available. The study of lipidomics is of particular interest, as the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a constantly evolving organism such as that of a newborn is extremely important.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who have given birth in hospital at any gestational age
* Written informed consent
* BMI 18.50-24.99 Kg/m2
* Varied and balanced maternal diet without restrictions
* Weight gain during pregnancy up to 12kg

Exclusion Criteria:

* Food intolerance
* Celiac disease
* Vegan or vegetarian diet
* Diet with the exclusion of milk and derivatives
* Diagnosis of metabolic diseases
* Taking medicines during pregnancy
* Withdrawal of informed consent
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)

This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ROS1 translocation. Crizotinib may block a protein called ROS1, which may be needed for cancer cell growth. Researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE:

Patients receive crizotinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
* Patients must be positive for translocation or inversion events involving the ROS1 gene via the MATCH Master Protocol
* Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)

Exclusion Criteria:

* Patients must not have NSCLC with ROS1 rearrangements
* Patients with a history of interstitial lung disease or pneumonitis are excluded
* Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition
* Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will be excluded
* Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib, ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072, KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

This study is being done to assess the safety and efficacy of using mobile application-based Bristol stool scale to titrate lactulose in prevention episodes of hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written, informed consent.
* Currently taking lactulose daily for prevention of hepatic encephalopathy.

Exclusion Criteria:

* Recent change in dosing of opioid medication.
* Previous Colorectal Surgery.
* Active diarrheal illness.
* Lack of smartphone or other smart device at home.
Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration


Eligibility Criteria:
Inclusion Criteria:

* Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
* Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
* Visual acuity between 20/320 and 20/40

Exclusion Criteria:

* Active ocular infection
* Contraindication to pupil dilation in either eye
* Eye surgery including cataract surgery and/or laser of any type within 3 months
One-hoUr Troponin Using a High-sensitivity Point-Of-Care Assay in Emergency Primary Care

Acute chest pain is a prevalent medical emergency in primary emergency care settings. Triage of chest pain prior to hospital admission presents significant challenges due to the absence of sufficiently sensitive diagnostic tools. Clinical signs, symptoms, risk assessment scores, or a normal electrocardiogram (ECG) can reliably exclude acute myocardial infarction (MI). This diagnostic uncertainty has resulted in chest pain being the second most common cause for acute hospital referrals from Norwegian emergency primary care, even though chest pain is frequently non-cardiac in origin.

In acute MI events, cardiac troponins are released into the bloodstream from the damaged myocardium, where low values are used to exclude MI. Until recently, such testing has necessitated using high-sensitivity cardiac troponin (hs-cTn) assays, which have been limited to hospital laboratories. However, recent technological advancements in point-of-care (POC) testing allow access to whole-blood assays that meet high-sensitivity criteria.

In this upcoming project, the investigators will evaluate the implementation of a whole-blood POC assay (QuidelOrtho TriageTrue hs-cTnI) across six Norwegian emergency primary care clinics. The study plans to enrol 2,500 patients over a period of 1.5 years. The clinical performance of the novel strategy will be investigated, as well as its impact on healthcare utilization and hospital referrals compared to standard care. Additionally, the investigators will assess the prevalence of persistent chest pain and its effects on quality of life, alongside psychological stress and anxiety, through validated questionnaires.

This project aims to offer better and more comprehensive management of the large group of emergency primary care patients with acute chest pain, contributing to reduced hospital referrals, improved quality of life, and more sustainable use of healthcare services.


Eligibility Criteria:
Inclusion Criteria:

* Patients (18+ years) with non-traumatic acute chest pain presenting in emergency primary care
* Troponin testing requested by the treating physician

Exclusion Criteria:

* Acute STEMI (direct hospital referral required)
* Haemodynamically unstable (direct hospital referral required)
* Not able to provide written, informed consent (i.e., due to time restraints, language barriers, impaired cognitive function, or other reasons)
The Relationship Between Cervical Radiculopathy and Eye-hand Coordination

this study will be conducted to investigate if there is a relationship between cervical radiculopathy and eye-hand coordination.

Cervical radiculopathy is a disorder involving dysfunction of the cervical nerve roots commonly secondary to cervical spine degenerative changes such as disk herniation and/or foraminal stenosis compressing the nerve roots. Clinical manifestations are pain in neck and one or both of the upper extremities, as a result of compression or irritation of nerve roots in the cervical spine. It can be accompanied by motor, sensory, or reflex deficits. It is most common in persons 45-60 years of age, which result in terrible chronic pain. Eye hand coordination is the ability to do activities which require the simultaneous use of hands and eyes. It is a complex cognitive skill which unites visual and motor skills in the person and allowing the hands to guide by the visual stimulations. It lies at the core of our daily activities and interactions with objects and people around us as to be a defining characteristic of typical human life. Previous studies show that there was a marked alteration in the hand function in subjects with the cervical radiating pain. Since there was no study which investigated the relationship between cervical radiculopathy and eye hand coordination despite it is an important skill that adults use in countless activities of daily living and during working.

Eligibility Criteria:
Inclusion Criteria:

* Subjects normal with no neck complain.
* Patients of cervical radiculopathy due to cervical discogenic lesion.
* Ages range from 30-50 both males and females.
* Subjects should be able to follow simple verbal commands or instructions included in the procedures.

Exclusion Criteria:

* Participants with any neck trauma.
* Cervical Post-operative patients.
* Participants with vision deficiency.
* Participants with perceptual and cognitive problems with score less than 24 in mini mental state scale (Appendix I) (Goudsmit et al., 2018).
* Participants with any other neurological or musculoskeletal problems.
* Participants take medications that affect their attention.
* Participants have space-occupying lesions eg. tumors
Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.

Exclusion Criteria:

* Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer
Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer

Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer

Exclusion Criteria:

* Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded
* Planned intermittent or short-term (\< 12 months) degarelix treatment
* Planned addition of, or switch to another form of androgen deprivation therapy during the study
Quantra Point-of-Care Hemostasis Monitoring

The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).

The Investigators propose a randomized control trial to assess patients scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass.

Patients will be randomized 1:1 to routine care or POC Quantra QPlus System. The total number of blood and blood component transfusions (including RBC, plasma, cryoprecipitate, and platelets) during and after cardiac surgery until 12 hours after ICU arrival will be analyzed between the groups.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years or more
2. Scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass (high-risk surgery includes reoperative surgery, active endocarditis, expected need for intraoperative circulatory arrest, radiation heart disease, end-stage kidney disease requiring renal replacement therapy, combination surgery including more than one valve or valve plus CABG, low left ventricular ejection fraction \[EF\<30%\] with potential need for mechanical circulatory support with intra-aortic balloon pump, extracorporeal membrane oxygenation \[ECMO\], pulmonary thromboembolectomy or percutaneous left ventricular assist device (VAD), and planned placement of a durable left VAD with or without placement of RV assist device.

Exclusion Criteria:

1. Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
2. Preoperative abnormal coagulation disorder (platelet count below 100,000/uL and/or aPTT \>40 seconds in the absence of heparin therapy. Prolonged aPTT \>40 seconds in the acceptable if due to heparin therapy.)
3. Liver disease, defined as a history of cirrhosis, liver enzymes \>3x normal range or manifested by elevated PT suggesting abnormal liver synthetic function not explained by other comorbidities
4. Pregnancy or breastfeeding
5. Refusal to accept red blood cells and blood component transfusions.
6. Contraindications to proposed interventions.
7. Unable to understand English as a first language or unable comprehend the study and/or the consent forms.
8. Vulnerable patients including prisoners, human fetuses, and neonates