cyrilzakka/clinical-trials huggingface dataset:
Effects of Insulin Treatment on Postprandial Platelet Activation in Patients With Non-insulin-dependent Diabetes Mellitus (NIDDM)

The postprandial phase in diabetic patients is characterized by a rapid increase in blood glucose levels, increase in platelet aggregation, LDL oxidation and over production of thrombin.

The aim of the study is to determine whether meal induced platelet activation is related to post-prandial hyperglycemia, and can be attenuated by good postprandial glucose control with rapidly acting insulin in patients with T2DM.

Each patient is admitted in the fasting state, on 3 different occasions . Blood glucose levels are normalized using intravenous infusion of insulin aspart , to a blood glucose level of 6-7 mmol/l. 15 minutes after normalization ,and right before a standardized meal, the patient is given a subcutaneous injection of insulin aspart 0.1 U/kg, 0.2 U/kg or placebo. The order of injections in the cross over study is randomized and blinded to the patient and to the investigators. The patient eats the meal and is followed up for 90 minutes after completion of the meal.

Blood tests for platelet function and other parameters are taken at 3 main points: 1. before glucose normalization.

2. 15 minutes after glucose normalization, and right before the meal. 3. 90 minutes after the meal.

Platelet function is evaluated by flow cytometry in whole blood (P- Selectin expression, Fibrinogen binding,aggregate formation: platelet- leukocyte, platelet-platelet, platelet-monocyte). Agonists that are used for platelet activation in flow cytometry are the thromboxane analogue U46619, ADP, and a collagen peptide that activates GPVI. Platelet adhesion is measured by the IMPACT cone and platelet analyser.

Eligibility Criteria:
Inclusion Criteria:

* Type II Diabetes Mellitus.
* Antecubital forearm veins allowing technically good sampling for platelet studies.
* HbA1c 6-9 % (Mono-S method).
* Below 70 years

Exclusion Criteria:

* History of a cardiovascular disease; Ischemic heart disease, Stroke, Peripheral vascular disease.
* Acute or chronic renal or liver disease
* Contraindication to insulin treatment
* Treatment with Glitazones, Sulphonylurea, antiplatelet drugs,
* Thrombocytopenia \<150 X109/l.
Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients

This study will evaluate the ability of short-term fasting to reduce chemotherapy toxicity and enhance anti-tumour response in patients with colorectal carcinoma subjected to chemotherapy.

Fasting for 24-48 hours during chemotherapy improves the response of the immune system against tumors and reduces chemotherapy toxicity through yet unknown mechanisms. The investigators have found that fasting induces the activation of p21, a protein that stops cell proliferation and plays important immune roles. The investigators hypothesize that p21 induction with short-term fasting enhances the immune anti-tumour response and reduces chemotherapy toxicity. To test this, half of the colorectal carcinoma (CRC) participants will follow 48 hours of fasting, 24 before and 24 after chemotherapy, under constant and specialized nutritional supervision. While the other half will follow a standard diet. A complete blood immunological profile at each chemotherapy cycle will be generated in collaboration with expert cytometrists, and gene expression, biochemical parameters, tumor evolution and toxicity markers will be measured. The investigators will (1) perform a complete analysis of immune cells to characterize the immune effects of fasting during chemotherapy; (2) analyze the effects of fasting on genes, metabolites and other molecules, to identify the responsible biological mechanisms, focusing on p21; (3) assess the reduction of chemotherapy toxicity in patients of colorectal carcinoma subjected to short-term fasting during chemotherapy.

Our project will further explore a safe, inexpensive, relatively unexplored and powerful nutritional intervention that can improve the quality of life and survival rates of millions of cancer patients: short-term fasting. Also, our project will have an important scientific impact, since previous reports have not yet described a clear mechanism explaining the beneficial effects of short-term fasting with chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* Participants with malignant colorectal neoplasia
* Good metabolic state (BMI\>22)
* Good nutritional tests
* Normal Haematological and biochemical parameters
* Normal renal and hepatic function
* No loss of weight during the chemotherapy treatment

Exclusion Criteria:

* BMI\<22
* Pregnancy or lactating women
* Bad nutritional state
* 3% weigh loss during the last month or more than 5% in the last three months
* Diagnosis of type 2 diabetes mellitus or hypertension
* Diagnosed hepatic, renal or cardiovascular disease
* Respiratory of psychiatric disease
* Nausea or vomiting, gastrointestinal disease
Stimulate the Face to Improve Tactile Acuity on the Hand

The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age: 30-80 years old
* Patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke
* Stroke event dates at least 3 months before the date of inclusion to the study
* Mild-to-moderate sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
* Capacity to provide written consent
* Affiliation to a social security scheme

Non-Inclusion Criteria:

* Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
* Severe speech disorder, global aphasia and/or cognitive impairment
* Multiple stroke events
* Bilateral stroke event
* Hemineglect
* History of neurological or psychiatric illness
* Allergy to glue/tape
* Male participants refusing to shave their moustaches or beards during the study
* Other experimental procedure is forbidden during the weeks where the study is performed
* Pregnant, parturient and lactating women
* Persons deprived of their liberty
* Adult persons subject to a legal protection measure: guardianship, curatorship
* Congenital or acquired malformation/injury of the test finger

Exclusion Criteria:

* Impossibility to maintain hand position necessary for the tests due to severe spasticity
* Severe impairment of the sensibility of the face preventing the administration of the RSS
* Severe impairment of the absolute touch detection at the affected hand preventing measurement (threshold 512 mN)
Optimization of Bedside Chest X-rays Taken in the Intensive Care Unit by Using Current Software-based Techniques

This study investigates how to utilize an algorithm-based virtual grid in lung imaging in intensive care unit patients. The aim is to compare the radiation dose caused by imaging with a virtual grid and a traditional grid and relate this to the achieved image quality. The study aims to determine how the radiation dose can be lowered and still obtain the same diagnostic image quality as using a traditional scatter-limiting lattice.


Eligibility Criteria:
Inclusion Criteria:

* All patients in the intensive care unit with an imaging of the lung.

Exclusion Criteria:

* Pregnancy
Diclofenac Potassium With Lidocaine Cream in Reducing Pain During HSG

The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.


Eligibility Criteria:
Inclusion Criteria:

* any patient came for HSG

Exclusion Criteria:

* any patient has contraindication to HSG
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM

This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.

Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.

The total trial maximum duration for the individual subject will be up to 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 and 64 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
* Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
* Stable insulin treatment at least 3 months prior to the screening visit
* Stable disease with HbA1c \<9.0 %
* C peptide \<=0.30 nmol/L
* Body mass index (BMI) \< 30.0 kg/m2

Exclusion Criteria:

* Type 2 Diabetes mellitus
* Previous participation in this trial. Participation is defined as being randomised
* Receipt of any medicinal product in clinical development within 60 days prior to this trial
* Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease
* Known or suspected hypersensitivity to the trial products or related products
* Severe hypoglycaemic events within one month prior to screening, as judged by the investigator
* Recent administration of glucagon (within 3 months prior to Screening)
* Clinically relevant diabetic complications as judged by the investigator
* Women of child bearing potential not willing to use contraceptive methods
REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)

The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF)

Changes in physiologic data are expected to correlate with 30-day readmission rates in this population

This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge

The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia

The study objectives are:

* Collect and characterize physiologic data from subjects with acute decompensated heart failure.
* Characterization of data related to health care utilizations within 30-days Post-discharge
* Correlation between patch monitor collected data and inpatient clinical data
* Correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)

Eligibility Criteria:
Inclusion Criteria:

* Subject with acute decompensated heart failure
* Subject (or legal guardian) willing to give consent for their participation
* Subject ≥18 years of age

Exclusion Criteria:

* Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months
* Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG Lead II orientation)
* Subject with known allergies or hypersensitivities to adhesives or hydrogels
* Subject with implantable devices with active minute ventilation sensors.
* Subject who will not comply to study protocol requirements. This includes completing required data collection, and attending required follow up study visits.
HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18 years and older, female.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. Patients must have platinum-resistant disease
5. Be able to provide fresh or archived tumor tissue.
6. At least one measurable lesion according to RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
8. With a life expectancy \> 12 weeks.
9. Adequate bone marrow reserve and organ function.
10. Contraception is required during the trial.

Exclusion Criteria:

1. Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
2. Previous or co-existing malignancies.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
4. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
6. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
7. Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.
8. Other inappropriate situation considered by the investigator.
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)

The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. Part 1 will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation. Part 2 will evaluate the efficacy and safety of belzutifan plus palbociclib at the dosage level determined in Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer \[AJCC\], 8th Edition) RCC with clear-cell component
* Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
* Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
* Has recovered from all AEs due to previous therapies

Exclusion Criteria:

* Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has clinically significant cardiac disease
* Has moderate to severe hepatic impairment
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
* Has received prior treatment of belzutifan or palbociclib
* Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
* Has had major surgery ≤3 weeks prior to first dose of study intervention
* Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin \[EPO\]) ≤28 days prior to the first dose of study intervention
Proparacaine vs Placebo for Corneal Injuries

Introduction: Traumatic injuries to the outer covering of the eye (the cornea) are a common emergency department complaint. They cause significant patient distress including pain, loss of sleep and missed work days. There is currently no accepted, uniform approach to pain management in this patient population. Emergency medicine and ophthalmology texts state that prolonged use of medications that anesthetize the cornea is not recommended. Several recent publications in the ophthalmology literature show that the outpatient use of dilute local anesthesia in patients after eye surgery is a safe and effective method of pain control. In this study, we used Proparacaine (a local anesthetic), in a similar manner, for the outpatient emergency department management of traumatic corneal injuries.

Methods: We performed a clinical trial on a sample of adult patients presenting with traumatic corneal injuries to two university affiliated emergency departments in London, Canada.

Patients providing signed informed consent to participate in the study received a vial of clear liquid that contained either Proparacaine or plain water (placebo), a pain log, topical antibiotics and oral Acetaminophen (Tylenol) with Codeine for breakthrough pain.

Patients were instructed to use the "study drug" on an "as-needed" basis for the next seven days. Patients completed a pain scale describing their discomfort immediately prior to, and five minutes after self-administration of the study drug. All patients were followed closely in an ophthalmology outpatient clinic on Days 1, 3 and 5 after presentation to the emergency department. At the last ophthalmology clinic visit, the patients' pain logs were collected.

The protocol was approved by the Research Ethics Board for Health Sciences Research Involving Human Subjects at the University of Western Ontario.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with acute (within 24 hrs) traumatic corneal injuries

Exclusion Criteria:

* immunocompromised
* known allergy to local anesthetic
* unable to consent /follow instructions for dosing / go to follow-up appointments
* previous ocular pathology
Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects

The purpose of this research study was to determine whether treatment with the bone grafting material Regenafil was as effective as the standard treatment using demineralized freeze dried bone allograft (DFDBA). Regenafil is demineralized freeze dried bone in a special gel form.

To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in a biologic thermoplastic carrier (Regenafil) to the standard of care. To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in the treatment of intraosseous vertical defects following six months of healing. This was accomplished by evaluating clinical parameters including probing depth, attachment level and bleeding upon probing, using attachment level as the primary outcome variable.

Treatment of the vertical osseous defect is a challenging problem in periodontics. There are many treatment options including:

1. open flap debridement;
2. osseous graft alone;
3. membrane alone;
4. or membrane plus an osseous graft.

Choice of treatment may depend on the defect depth and configuration. A shallow, narrow 3 wall defect may respond well to open flap debridement while a deep 2 wall defect may need regenerative therapy such as an osseous graft, a membrane or combined membrane and graft treatment. Studies of vertical defect therapy with defects about 4 mm or greater show that similar percent defect fill results are obtained with regenerative therapies. Open flap debridement produces substantially less percent defect fill.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent prior to their participation.
2. Be an adult age 18 and older.
3. Have at least a 4 mm open vertical osseous defect depth on one tooth, visible on a radiograph and with a probing depth ≥ 5 mm.
4. Have osseous defects that are either wide 3-wall, or combination defects.

Exclusion Criteria:

1. Have debilitating systemic diseases, or diseases that affect the periodontium.
2. Have a known allergy to any of the materials that will be used in the study:

   * non-steroidal anti-inflammatory drugs (NSAIDs)
   * chlorhexidine digluconate
   * doxycycline
   * gelatin
3. Need prophylactic antibiotics.
4. Have a vertical osseous defect that is related to a furcation area.
5. Smoke more than 1 pack per day.
6. Have endodontically treated teeth or endodontic lesions at study sites.
7. Have 1-wall defects.
8. Have poor oral hygiene.
9. Have anterior fillings (Note: if a subject presents with anterior fillings, it will be at the discretion of the principal investigator as to whether they should be accepted into the study.)
10. Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.
Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue Diseases in Egyptian Patients

* Measuring the incidence and prevalence of PAH in Egyptian patients with different types of MCD
* Determination of survival \& the risk factors of mortality.

PH is defined as a mean pulmonary artery pressure greater than 25 mmHg. PAH can be assessed by different means, however right heart catheterization (RHC) is the gold standard diagnostic method .

Among the different subgroups of pulmonary arterial hypertension (PAH), those associated with connective tissue diseases (CTDs) are a specific entity with distinct hemodynamic and prognostic features reflecting the importance of a rheumatological assessment in PAH, especially with the unfavorable prognostic impact in these patients.

Compared to patients with idiopathic PAH, patients with CTD-associated PAH have a higher mortality and a lower walking distance on the 6-minute walk test, higher levels of B-type natriuretic peptide, worse right ventricular function, more left-sided heart dysfunction, lower lung function, and more pericardial disease.

That's why, PAH screening is routinely performed in systemic sclerosis (SSc) and in other CTDs and also, as suggested by international guidelines, it is important to rule out CTDs in patients with PAH, because patients diagnosed as idiopathic PAH (iPAH) may have an associated CTD previously unrecognized.

Although the similarities in pathogenesis of PAH in CTD such as systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and mixed connective tissue disease (MCTD), there are variabilities in outcomes in patients with CTD-associated PAH.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed as connective tissue diseases fulfilling ACR criteria will be recruited

Exclusion Criteria:

non

-