cyrilzakka/clinical-trials huggingface dataset:
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Japanese and Caucasian subjects
* Age between 20 and 55 years (both inclusive) at the time of signing informed consent
* Body weight of equal to or above 54.0 kg
* Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%
* For Japanese subjects only: both parents Japanese
* For Caucasian subjects only: both parents Caucasian

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Calcitonin above or equal to 50 ng/L
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits
* Smoking of more than 5 cigarettes (including nicotine substitute products) or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
* Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)

Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2 diabetes.

This study aims to explore the effect of diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.

This study is a randomised, multicenter controlled trial Our Aim is to test the effects of an 8-week diet lacking red meat, containing increased fibers and coffee (verum) versus standard recommendation (control)in a multicenter setting.

We are expecting that the verum diet will improve insulin sensitivity and insulin secretion due to reductions in visceral and hepatic fat along with improved adipocyte cytokine secretion profiles

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* disease duration for five years or less,
* age of 69 years or less,
* body mass index of 30 kg/m2 or more,
* hemoglobin A1c of 5,5 % to 9%
* patient should be on standard diet or metformin +/- acarbose monotherapy
* patient should be without exclusion criteria for coffee consumption

Exclusion Criteria:

* disease duration more than five years,
* age of \> 69 years,
* body mass index of \< 30 kg/m2,
* hemoglobin A1c \< 5,5 % or \> 9%
* if patient becomes insulin therapy
* if patient has exclusion criteria for coffee consumption
* if patient is non-compliant with study protocol
* if patient is pregnant
* if patient has acute infection
* if patient has anaemia
* if patient has malignancies
* if patient has autoimmune or immune compromising diseases including HIV/AIDS
* if patient has psychiatric diseases or addiction
Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort I: Veno-arterial Extracorporeal Membrane Oxygenation (PLUTO-I)

Invasive pressure-volume (PV) loop measurements have the potential to confirm or refute earlier computer simulations and animal studies regarding changes in cardiovascular physiology induced by (veno-arterial) ECMO. PV loop analysis could create a framework for the (ICU-) clinician for VA-ECMO weaning guidance, based on a patient's individual hemodynamic profile. PV loop measurements may, in future, serve as a guide for which patient would benefit most from (prolonged) VA-ECMO support or which patient would require additional LV unloading. Within the context of PLUTO-I, patients on VA-ECMO support who are eligible for weaning from VA-ECMO will undergo biventricular PV loop measurements on different intensities of extracorporeal support.

Using VA-ECMO support, physiological stability can be maintained in patients with refractory hemodynamic failure as bridge to recovery, definitive therapy or decision making. Previous animal studies and computer simulations hypothesize increased LV afterload as well as RV distention during VA-ECMO. Decision making concerning VA-ECMO weaning is largely based on bedside hemodynamic (including echocardiographic) parameters. Profound details of the effects of VA-ECMO on elemental cardiac physiology, including myocardial metabolic efficiency and ventricular-arterial coupling, are limited. We hypothesize biventricular pressure-volume loop (PVL) measurement will enhance understanding of elemental cardiovascular physiology including ventricular interdependence during different levels of VA-ECMO support. PVL measurement will hypothetically provide opportunities in discovering novel predictors for successful weaning from VA-ECMO support. For the purpose of PLUTO-I, patients on VA-ECMO who are eligible to wean will undergo invasive PV-loop measurements on different intensities of extracorporeal flow.

Eligibility Criteria:
Inclusion Criteria:

- On VA-ECMO support for any indication

Exclusion Criteria:

* Age \< 18 years
* Re-initiation of VA-ECMO during the same ICU admission
Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease

During the previous phases of the project (Phase I and II), two new field tests have been designed and validated for an integration in a primary care setting in Chronic Obstructive Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted, particularly by the reduction of dyspnea level following bronchodilatation, Phase II highlight that the 3MPST does not allow to detect this decrease of dyspnea after bronchodilatation. The use of too high step rates could explain these results through a hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial is to follow the investigations on the sensitivity of 3MPST to detect the effects of pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of this work is that the use of lower step rates cadences could allow to detect an improvement of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step rates.

For this project, 40 patients with COPD will be recruited in 2 centres (in the Institute of Cardiology and Pneumology of Quebec and in the Chest Institute of Montreal). For each patient, three visits will be performed. During the first visit, baseline pulmonary function and maximal exercise capacity will be evaluated and the patients will be familiarized with step test proceedings. Between the different visits, a 3-7 days period will be respected. During the second and the third visits, 4 step tests will be performed at 4 different rates, following one of the two conditions (placebo or bronchodilatation). This project will propose two randomization levels. The first randomization will be relative to the choice of the condition used during the second visit (placebo ou bronchodilatation) and the second one for the rates order (14, 16, 20, 24 steps/min). During each performed exercise, cardiorespiratory and pulmonary parameters will be measured using a portable system.

Eligibility Criteria:
Inclusion Criteria:

* age higher than 50 years old
* smoking history ≥ 10 packs/year
* post-bronchodilator FEV1 between 30 and 80% of the predicted value and FEV1/FVC lesser than 70% as assessed in previous pulmonary function test (corresponding to GOLD stages II and III)

Exclusion Criteria:

* respiratory exacerbation within the preceding 6 weeks
* asthmatic condition
* significant O2 desaturation (SaO2 \< 85%) at rest or during exercise
* presence of another pathology that could influence exercise tolerance or may prevent the realization of the step test
* subject having a pacemaker
Long Term Impact of Covid-19 Vaccination on Adolescence

Long term impact of COVID 19 vaccination on dizziness-related disability and balance in adolescence


Eligibility Criteria:
Inclusion Criteria:

* Adolescence age range 10-18
* Vaccinated by any available SARS -COV-2 Vaccinations

Exclusion Criteria:

* If the subject infected by COVID-19 before.
* Not vaccinated.
* Having any inner ear related conditions
* Having a previous balance disorder prior the vaccination
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI).

This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access. The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death, MI, stent thrombosis and urgent revascularization and bleeding up to 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Scheduled for elective or ad-hos PCI
* Aspirin use daily for greater or equal to one week
* Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

Exclusion Criteria:

* Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or Tnl greater or equal to 0.4ng/dl
* administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the previous 30 days
* Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks
* Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks
* Platelet count less than hundred thousand per cubic millimeter or hematocrit \<33% or hemoglobin \<11 g per deciliter
* Subjects who received full dose low molecular weight heparin within six hours prior to randomization
* Allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year
* Scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (eGFR\<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the PCI procedure
Impact of Milk Fat Globule Membrane Supplementation on Heart and Brain Health

In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40 - 70 years
* BMI: 25-45 kg/m2
* Recreationally active (\> 3 x 30 min moderate exercise per week)
* Understands and is willing and able to comply with all study procedures, including changes to diet
* Fluent in written and spoken English
* Access to, and able to use, the internet/computer/tablet device

Exclusion Criteria:

* Smoking (including vaping)
* Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
* Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
* Diagnosed with cardiovascular disease or suffered myocardial infarction/stroke in the past twelve months
* Existing or significant past medical history of any medical condition likely to affect the study outcomes.
* Prescribed medications or supplements likely to interfere with study outcomes or prescribed antibiotics within the last three months
* Use of antidepressant/anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period.
* Known allergy or intolerance to study food (lactose intolerance, dairy)
* Being vegan or any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
* Excessive alcohol consumption: \>21 unit/wk
* Pregnancy, seeking to become pregnant or active lactation
Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy

The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.

This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load below 10,000 copies/ml.
* Have a CD4 count between 300 and 500 cells/mm3.
* Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI).
* Are at least 18 years old.
* Agree to use an effective barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.)
* Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate.
* Have cancer requiring chemotherapy.
* Have a history of autoimmune disease.
* Have uncontrolled diabetes or certain thyroid problems.
* Have mental illness or other serious medical condition that the doctors feel would affect their ability to participate.
* Have received IL-2 in the past.
* Have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks.
* Have taken hydroxyurea in the past 4 months.
* Are pregnant or breast-feeding.
Comparison of Produce Prescription Benefit Dosage

The goal of this study is to determine the relationship between produce prescription program 'dose' on benefit redemption, food insecurity, and fruit and vegetable consumption. Participants will be randomized to receive one of three fruit and vegetable benefit dose amounts for 6 months ($40, $80, or $110/month).

Emerging evidence from the growing body of research around 'Food is Medicine' interventions shows promise that produce prescriptions (PPR) improve health by enabling purchases of healthy foods, reducing food insecurity, and improving diet quality. However, PPR amounts are often set seemingly arbitrarily, without clear connection to their intended purpose. In this study, investigators will conduct a three-armed randomized trial of 240 participants in Stockton, CA to test the impact of three 'doses' of a fruit and vegetable benefit on benefit redemption, food security, and fruit and vegetable intake. The goal of this study is to determine the relationship between PPR program 'dose' and the key intermediate outcomes of benefit redemption (primary outcome), food insecurity, and consumption of incentivized foods (secondary outcomes). Investigators will also seek to identify any 'ceiling effect' above which further increases in benefit value do not lead to further benefit redemption. This will be highly informative for subsequent PPR research. Investigators will leverage the existing infrastructure of the Vouchers 4 Veggies - EatSF produce prescription program to ensure feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Individual enrolled in a First Five Program at El Concilio California, located in Stockton, CA
* Age 18+
* English or Spanish speaking
* Literacy sufficient to complete a written survey
* Technologic capacity to complete an online survey

Exclusion Criteria:

* non English or Spanish speaking
* cognitive impairment severe enough to interfere with understanding of the survey or consent form, whether due to cognitive delay, substance abuse, dementia, mental illness, or other etiologies
* Not enrolled in a First Five Program at El Concilio California
Bridging the Gap by Transitional Care

The purpose of the study is to evaluate patient adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management

It is a prospective, randomized, controlled Study. Patients randomized in a 1:1 ratio to pharmacist counseling or standard of therapy prior to discharge.

Standard therapy: Nurses distribute a education pamphlet on diabetes.

Pharmacist Counseling includes but is not limited to:

* Reviewing and explaining their medications (dosing, side effects, route)
* Reviewing symptoms and complications of hyper and hypoglycemia
* Defining glycemic \& non-glycemic goal levels
* Explaining the importance of compliance with medications \& appointments
* Educating on the basics of nutrition and physical activity

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* 18 to 85 years of age
* Historical diagnosis of type 2 diabetes mellitus greater than one year
* HbA1c concentration ≥ 8%
* Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County
* Patient with provider and prescriptions filled within CCHS

Exclusion Criteria:

* Type 1 diabetes mellitus
* Pregnancy
* Major illness or debility, that prohibits the subject from participating in the study
* History of any hemoglobinopathy that may affect determination of HbA1c
* Non-English speaking patients
A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type

IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.

Eligibility Criteria:
Inclusion Criteria:

1. ENKTL diagnosis;

   * Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type
   * At least 1 previous line of systemic therapy
   * Documented disease progression of last therapy
2. Adult age(as defined by respective country)
3. The nature of the study and voluntarily sign an ICF
4. ECOG 0 or1
5. Adequate hematologic function, hepatic function, and renal function

Exclusion Criteria:

1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
2. Known presence of symptomatic CNS metastases
3. Prior allogeneic HSCT or solid organ transplantation
4. Any active autoimmune disease or a documented history of autoimmune disease
5. Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
6. Pregnant or lactating
Endogenous Glucose Production in Patients With Glycogen Storage Disease Type Ia

Glycogen storage disease type Ia (GSDIa) subjects retain a limited capacity for endogenous glucose production (EGP). To date, the origin of residual EGP in GSDIa patients is unknown. Either increased glycogen debranching or lysosomal glycogen breakdown can account for residual EGP in GSDIa.

Innovative treatments for GSDIa (e.g. AAV8-mediated gene therapy and mRNA therapy) are being developed.Therefore, longitudinal minimally-invasive monitoring of outcomes after therapeutic interventions in GSD Ia subjects becomes warranted.

The primary objective is to test the feasibility of EGP quantification in adult GSDIa subjects by stable isotopes after a single oral \[6,6-2H2\]glucose dose. Secondary objectives are to compare EGP assessed by a single oral \[6,6-2H2\]glucose dose (a) in GSDIa patients versus matched healthy participants, (b) among GSDIa patients, (c) in the pre-prandial state versus the fed state, (d) in the controlled hospital setting versus the home setting. Data collected from the continuous glucose monitoring data will also be compared

Study design: An investigator-initiated human pilot-study. Study population: Ten adult subjects with GSDIa and ten age and gender-matched healthy subjects.

Interventions: Three experiments will be performed for each subject. During the first in hospital experiment, two oral D-\[6,6-2H2\]glucose loads will be performed 2 hours before breakfast and at lunchtime, respectively. The third oral D-\[6,6-2H2\]glucose load will be performed at home (random time). Capillary blood samples will be collected on filter paper at specific time points after each oral D-\[6,6-2H2\]glucose load. During the experiments, subjects will be monitored by subcutaneous continuous glucose monitoring (CGM).

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis should be confirmed by G6PC mutation analysis
* Age above 16 years
* Stable medical condition before the start of the test procedures

Exclusion Criteria:

* Age \< 16 years
* Intercurrent illness
* Recent history of hospitalization due to hypoglycemia
* Pregnancy
* History suggestive of diabetes or fasting intolerance
* First grade family member with a confirmed diagnosis associated with fasting intolerance