cyrilzakka/clinical-trials huggingface dataset:
Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia

This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign written informed consent prior to study entry.
* Participants who self-identify as Asian; male or female, \>18 years of age.
* Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).
* Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
* Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
* Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.

Exclusion Criteria:

* Fasting plasma glucose \>220 mg/dl at screening.
* Impaired kidney function, eGFR of \<60 mL/min/1.73 m2 at screening.
* BMI \>35 kg/m2.
* Weight ≤ 50 kg.
* Elevated liver transaminase \> 3 ULN at screening.
* Ongoing or recent (i.e. \< 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.
* Ongoing or recent (i.e. \< 3 month) injectable insulin therapy.
* Ongoing or recent (i.e. \< 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss \>5% within previous 6 months.
* Ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
* Major medical/surgical event requiring hospitalization in the last 3 months.
* Known allergy and intolerance to product components or paracetamol.
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
* Are unable to comply with protocol procedures in the opinion of the investigator.
* Have a hierarchical link with the research team members.
* Positive pregnancy test or breast-feeding at screening.
* Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
* Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects

This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects

This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. Age 18 through 50 years at the time of screening.
3. Female subjects must be of non-childbearing potential.
4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.
5. Body mass index of 19.0 through 32.0 kg/m2 at screening.
6. No clinically significant abnormality on the basis of medical/medication history or physical examination.
7. Negative drugs of abuse (DOA).
8. Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
9. For the Japanese Cohort, both of the subject's parents and both sets of grandparents must be Japanese.

Exclusion Criteria:

1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
2. Concurrent enrollment in another clinical study involving any treatment.
3. Individuals who are legally institutionalized.
4. Receipt of \> 2 marketed or investigational biologic agents.
5. Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.
6. Receipt of any investigational non biologic agent within 3 months or 5 half lives prior to screening, whichever is longer.
7. Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety.
8. Known history of allergy or reaction to any component of the investigational product formulation.
9. History of anaphylaxis following any biologic therapy.
10. Any clinically relevant abnormal findings in physical examination ECG, vital signs, and laboratory parameters.
11. Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).
12. Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at screening.
13. Receipt of live attenuated vaccines 30 days prior to the date of screening.
14. Where donation of blood or blood products was in excess of 500 mL within an 8-week period in the 3 months prior to screening.
Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study

Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes

We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement \> 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Acute ischemic stroke
2. Age 18 to 80 years
3. Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration
4. Stroke symptoms present for at least 30 minutes with no significant improvement before treatment

Exclusion Criteria:

1. patients with Intracranial hemorrhage
2. the symptoms of Time onset was unknown
3. Symptoms rapidly improving or only minor before start of infusion
4. Seizure at the onset of stroke
5. Stroke or serious head trauma within the previous 3 months
6. Administration of heparin within the 48 hours preceding the onset of stroke, with an activate
7. partial-thromboplastin time at presentation exceeding the upper limit of the normal range
8. Platelet count of less than 100,000 per cubic millimeter
9. Systole pressure greater than 185 mm Hg or diastole pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
10. Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter
11. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
12. Oral anticoagulant treatment
13. Major surgery or severe trauma within the previous 3 months
14. Other major disorders associated with an increased risk of bleeding
Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

Primary objective:

* Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

* Compare the following parameters following 4 cycles of VD or VTD induction treatment:

  * CR rate+ very good partial remission (VGPR) rate
  * Overall remission rate (CR + VGPR + partial remission (PR) rate)
  * K/l light chain ratio in patients in CR.
  * Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
* Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed symptomatic multiple myeloma (MM) patient
* Aged under 65
* Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
* Using effective contraceptive methods (for fertile men, women of childbearing potential)
* Provision of informed consent
* No evidence of active infection

Exclusion Criteria:

* Asymptomatic MM
* Non-secretory MM
* Aged 66 years or over
* ECOG performance status over 2 (see Appendix 2)
* Proven amyloidosis
* A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
* Positive HIV serology
* A personal medical history of severe psychiatric disease
* Severe diabetes contraindicating the use of high-dose dexamethasone
* NCI grade ³ 2 peripheral neuropathy
* Serum clinical chemistry:

  * creatinine level \> 300 µmol/L or requiring dialysis
  * bilirubin, transaminases or GamaGT \> 3 the upper normal limit (UNL)
* Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
* Radiation therapy in the 2 weeks preceding randomization
* A personal medical history of allergic reactions to compounds containing boron or mannitol
* Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure
* Use of any investigational drug in the 30 days preceding randomization
* Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
* Severe pulmonary troubles (including acute infiltrative pneumopathy)
Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months

The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.

2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.

Evaluation of the area under the ROC for Procalcitonin concentration.

Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

Eligibility Criteria:
Inclusion Criteria:

* Infant older than 7 days old and less than 3 months old.
* Fever (defined by a rectal temperature greater than or equal to 38°C)
* Emergency consultation

Exclusion Criteria:

* Infants with a previously identified immunodeficiency or chronic disease,
* Antibiotic treatment within the previous 48 hours
Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)

The prevalence of malnutrition in hospital is very high (30 percent) with major consequences in terms of morbidity and mortality, generating significant health care costs. The positive impact of its support is demonstrated.

The HAS (French High Sanitary Authority) recommends a screening of all adult hospitalized in the first 48 hours, with no consensus regarding the organization of screening within care services. Various strategies have been implemented. Although this screening is part of the nursing role, old and recent studies show that it is not done systematically and nutritional disorders are largely under-diagnosed and therefore untreated.

The investigators assume that an organization of screening for eating disorders, based on a caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour l'Amélioration de la Qualité et de la Sécurité des Soins) which is an indicator for the improvement of the quality and security of care) Screening indicator of nutritional disorders Level 3, compared to an organization "classic" involving the care teams in their entirety. This indicator reflects the care system performance.

In this study, patients will have no intervention. Only the organization of the care staff will be adapted but with no changes on the care of patients?

Undernutrition in the hospital is a public health issue. The impacts of this malnutrition are known , with consequences clearly established on the morbidity, mortality and quality of life. Undernutrition is an independent risk factor for mortality (5). In terms of morbidity, the most frequently reported consequences are infections, postoperative complications (delayed healing, in particular nosocomial infections, risk of pressure ulcers) and pejorative impact on the prognosis of chronic diseases such as respiratory failure , heart and kidney.

Malnutrition therefore affects the length of hospital stays and the burden of care.

Many studies have shown the positive impact of the medical care of malnutrition on morbidity and mortality, whether intervention studies in general hospital population or in specific pathologies.

But there is no systematic screening strategy undernutrition implementation in hospitals.

The investigators assume that the organization of screening for eating disorders based on a caregiver specifically dedicated to this activity, improves the indicator IPAQSS Screening indicator of nutritional disorders level 3 compared with a "classic" organization shared between different actors of care. This indicator reflects the care system performance This organization must advance quickly and significantly the number of patients evaluated nutritionally and help reach a level of completeness close to 100%.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in medicine-surgery-obstetrics department
* Patient over 18 years

Exclusion Criteria:

* Patient hospitalized less than 48 hours
* Patients under 18 years
Estimation of the MCID for Patients With Knee Osteoarthritis

Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment.

It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed.

Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.


Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA)
* Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
* Participants with age between 50 and 70 years old
* Being able to walk without using an assistive device
* Having a body mass index of less than 30 kg/m²
* Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale

Exclusion Criteria:

* Patients who received physical therapy or intra-articular injections in the last 6 months
* Receiving an indication for surgery
* Have severe hearing, vision and speech impairment
* Having serious systemic and cardiovascular diseases that interfere with exercise
* Having a lower extremity deformity
* Patients with acute inflammation of the knee
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients

This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.

Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study

Exclusion Criteria:

* Diabetic, history of glaucoma
* history of iris trauma
* history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery
* Anisocoria
* pregnancy
Seoul National University Pituitary Disease Cohort Study

The purpose of this study is to investigate the treatment and natural history of pituitary disease. We have a longstanding interest in pituitary disease including acromegaly, central diabetes insipidus, and nonfunctioning pituitary adenoma. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to pituitary disease.

Subjects for this study will be recruited if they are:

1. Adults, male or female aged 18 years or older
2. Have been diagnosed with pituitary diseases

Eligibility Criteria:
Inclusion Criteria:

* Subjects for this study will be recruited if they are:

  1. Adults, male or female aged 18 years or older
  2. diagnosed with pituitary diseases such as acromegaly, Cushing's disease, hyperprolactinemia, nonfunctioning pituitary adenoma, pituitary stalk lesions, central diabetes insipidus, and craniopharyngiomas

Exclusion Criteria:

* Patients who do not agree with the study
A User Study of SYNUS Pain Relief Made by Tivic Health Systems

Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.

A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age and older
* Present with symptoms of sinus pain and pressure
* Have an initial sinus pain score of 4 or more on the visual analogue scale
* Be able to read and understand English
* Agree to participate in the study
* Be able and willing to provide Informed Consent

Exclusion Criteria:

* Do not meet Inclusion Criteria
* Have currently a dental infection
* Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention
* Be currently pregnant
* Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.


Eligibility Criteria:
Inclusion Criteria:

* Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe hemophilia B (Factor IX activity ≤2%).
* Subjects should not have received an infusion of any Factor IX products for at least 4 days before the administration of BeneFIX on Day 1.
* Subjects must be in a non-bleeding state before the administration of BeneFIX on Day 1.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Diagnosed with any other bleeding disorder in addition to hemophilia B.
* Current FIX inhibitor or history of FIX inhibitor (defined as \> Upper Limit of Normal (ULN) of the reporting lab).