cyrilzakka/clinical-trials huggingface dataset:
A First-in-Human Phase I Study of ESG206 in Subjects With B-cell Lymphoid Malignancies

This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK, and preliminary efficacy and to establish the MTD, if any, and RP2D(s) of ESG206 in adult subjects with B lymphoid malignancies.

This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The study will follow a modified 3+3 dose escalation scheme. Dose escalation will continue until identification of MTD or the predicted efficacy dose in the event that a MTD is not identified due to paucity of DLTs. Toxicity including dose-limiting toxicity (DLT) observed in Cycle 1 of the first 28 days will be used to determine escalation to the next dose level as described below.

Five dose levels are planned. Dose choosing will be determined by the SMC and the sponsor based on the pharmacokinetics, tolerability and preliminary antitumor activities, as well as other available data.

Subjects will be monitored for safety, tolerability, and efficacy throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent for the trial.
* Male or female and at least 18 years of age.
* Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable.
* Measurable or evaluable Disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject must have adequate organ function.

Exclusion Criteria:

* Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing.
* Had major surgery within 4 weeks before first dosing.
* Had undergone an autologous stem cell transplant within 100 days before first dosing.
* Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
* Pregnant or breastfeeding women.
* Unwillingness or inability to follow the procedures outlined in the protocol.
Corticosteroids for Cancer Pain

Study hypothesis: corticosteroids are effective for pain in cancer patients. We will perform a double-blind, randomized, placebo-controlled multicentre trial evaluating the effect of Methylprednisolone 16 mg twice daily in cancer patients with pain (average pain last 24 hrs NRS \> 4 (Numerical rating scale, 0 No pain, 10 worst pain).

Patients are required to use strong opioids before entering the study. Weak opioids are allowed if patients have short acting strong opioids as rescue-medication. The scheduled opioids shall be stable last 48 hours before entering the study and will be kept stable during the study period. Patients may use as much short acting rescue-medication as they require. No other analgesic medication should be started during the study period.

The study is a multicentre trial. Patients will be randomized according to 1. study centre (No 1-5) and 2. pain mechanism: skeletal metastases (yes/no).

Patients are evaluated Day 0 and Day 7 by palliative care physician. Patients will be contacted by phone Day 1-6 and will fill in questionnaire regarding symptoms and analgesic usage. Patients will be contacted Day 14 and 21 to fill in questionnaires regarding symptoms, quality of life and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Verified malignant disease
* Receiving a scheduled strong or weak opioid
* Insufficient pain control: Average pain last 24 h: ≥ 4 (NRS 0-10)
* Given informed consent according to the ethical guidelines
* Able to complete planned assessment schedules
* ≥ 18 years of age
* Life expectancy \> 1 month

Exclusion Criteria:

* Excruciating pain (average pain ≥ 8) (These patients should be considered as emergency patients. Patients may be eligible for the study after stabilization)
* Dose adjustment in scheduled opioid medication last 48 hours
* Concurrent medication with NSAIDs (Patients are eligible for the study one week after NSAIDs are discontinued)
* Receiving radiotherapy within 4 weeks before entering the study or planned within the study period
* Started systemic treatment (chemotherapy, hormone therapy or bisphosphonates) within 4 weeks before entering the study Patients who have received chemotherapy for more than 4 weeks are eligible for the study if it is more than 7 days since receiving the last dose and they are not having the next dose within the study period
* Manifest spinal cord compression or in need of bone surgery
* Severe cognitive impairment
* Previously on steroids during the last 4 weeks
* Diabetes mellitus
* Known peptic ulcer disease
* Systemic fungal disease, patients vaccinated with viable viruses, and patients with known allergies to the study medication (MethylPrednisolone)
* Female patients who are pregnant or lactating.
* Women of reproductive potential not willing or unable to employ an effective method of contraception (be sterilized, using IUD or oral contraception)
* Patients using following medication: cyclosporin, erythromycin, phenobarbital, phenytoin, carbamazepin, ketoconazole, methotrexate, ciclofosfamide, rifampicin, aprepitant and diltiazem.
Investigating the Consumption of Different Protein Rich Whole Food Sources on Muscle Growth in Trained Males and Females

Background To date, most of the literature investigating the role of dietary protein in muscle growth has focused on isolated protein sources. However, dietary protein is most commonly consumed within a whole food source. Consuming dietary protein within a whole food matrix may additionally stimulate muscle growth. The idea being, there may be other components within food, capable of producing a greater response.

Objectives: To assess the effect of consuming a variety of whole food sources, on the stimulation of muscle growth compared to an isolated protein source following a single bout of lower body resistance exercise.

Methods Young healthy resistance-trained volunteers will consume a protein rich whole food source, following a bout of lower body resistance exercise. Stable isotope IV infusions and repeated blood and muscle samples will be taken to assess protein digestion and absorption, as well as muscle protein synthesis rates.

Value of Research:

To determine whether whole food sources potentiate muscle protein synthesis rates (and to what extent across whole food sources) compared to an isolated protein source. In doing so, we can further investigate the nutrients involved that may be contributing to this effect.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* BMI 18.5 - 30 kg/m2
* Aged 18 - 40 years
* Structured Resistance training consistently for \> 6 months
* A 5-7 day "washout" period from any supplementation

Exclusion Criteria:

* Age \>40 years
* Body mass index (BMI) \<18.5 or \>30 kg/m2
* Any metabolic impairments
* Any cardiovascular impairments
* High blood pressure (≥140/90 mmHg)
* Any gastrointestinal disorders
* Any medications known to affect protein and/or amino acid metabolism
* A personal or family history of epilepsy, seizures or schizophrenia, motor disorder
* Chronic over the counter use of pharmaceuticals (\> 1 month)
* Allergic to any of the whole foods included in the study
Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort

The aim of this study is to test the effects of a digital meditation intervention in a sample of high stress UCR employees. We will randomize UCR employees to 8-weeks of either a digital mindfulness intervention (using the commercially available application Headspace) or a waitlist control condition.

Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for 10 minutes per day for 8 weeks. They will be asked to fill out short (no longer than 30 minutes long) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Participants who are randomized to the digital meditation intervention will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone), and on the participants' own time.

High levels of psychosocial work-related stress have major implications for both the employee and the employer. Epidemiological studies consistently demonstrate associations between high work stress and worse self-reported mental and physical health, including depression, anxiety, cardiovascular disease, and type 2 diabetes.

Job strain, a combination of high demands and low control, is a common model used to define psychosocial stress at work. Job strain is associated with worse mental and physical health, including anxiety and depressive disorders and increased blood pressure.

Past studies show the value in mindfulness applications. For example, participants who completed 25 or more meditation sessions over 8 weeks also had significantly lower self-measured systolic blood pressure over the course of one day compared to the control condition participants at the follow-up time point. This trial suggests that almost daily brief mindfulness meditations delivered via smartphone can improve outcomes related to workplace stress and well-being, with potentially lasting effects.

In this study, investigators hope to determine if a stress-reduction mindfulness application is more effective than a waitlist control condition in employees who are experiencing mild to moderate levels of stress in various health and productivity-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Have access to a smartphone or computer every day
* Are fluent in English
* Are a UCR employee
* Have moderate to high levels of stress
* Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent
* Are at least 18 years of age

Exclusion Criteria:

* Experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as 3-4 times or more per week)
Norwegian Microemboli in Acute Stroke Study

BACKGROUND: The cause of ischemic stroke remains undetermined in 30-40% of the cases, but circulating blood clots (thromboemboli) are a postulated common denominator in approx. 75% of patients. Transcranial Doppler monitoring (TCDM) is a non-invasive method of detecting circulating microemboli (CME) in the human cerebral circulation. The method is not used systematically in unselected groups of patients with repeated long-term registrations. New ultrasound equipment is ambulatory, less unpleasant for the patient and allows extended monitoring sessions. This may vastly simplify the implementation of TCDM as a clinically useful diagnostic tool.

AIMS: Determine the usefulness of TCDM in acute stroke diagnostics by assessing prevalence and frequency of CME in unselected patients with ischemic stroke, the influence of antithrombotic drugs on CME and the relationship between MES and recurrent stroke or transient ischemic attack (TIA).

HYPOTHESES: Prevalence and frequency of CME are higher during the first 24 hours than at later follow-up. Stroke etiology can be assessed by the presence or absence of CME. Presence of CME is associated with increased risk of recurrent TIA of stroke within 3 months and 1 year. Cessation of CME after the start of antithrombotic treatment is associated with reduced risk of recurrent TIA or stroke.

* Standardized questionnaire
* Clinical work-up in accordance with hospital standard operating procedures, i.e. radiological and cardiological procedures, neurovascular ultrasound, clinical scoring, etc.
* 1st Transcranial Doppler monitoring (TCDM) at admission if within 24 hours after stroke onset (day 1). TCDM is repeated at 18-36 hours and at day 3. Microembolic signals are automatically registered by the software and subsequently verified manually.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital \< 24 hours after onset of ischemic stroke

Exclusion Criteria:

* Temporal bone window inadequate for transcranial Doppler examination
* Participation in ongoing sonothrombolysis study (NOR-SASS 2)
* Reduced ability to cooperate
* No informed consent can be obtained
Evaluation of Safety and Efficacy of Allo GDA-201 Natural Killer (NK) Cells in Patients With Relapsed/Refractory B Cell NHL

This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved Natural Killer (NK) cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).

The study is divided into a phase I dose escalation phase and a phase II expansion phase.

Patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL) will receive GDA-201 followed by a short course of low-dose interleukin-2 (IL-2). Rituximab will be administered prior to and after GDA-201 infusion.

Phase I: Dose escalation phase The objective of Phase I is to evaluate the safety of GDA-201 in patients with FL, DLBCL/ HGBCL, marginal zone lymphoma or mantle cell lymphoma. The maximal tolerated dose (MTD) and recommended Phase II Dose (RP2D) will be determined based on dose limiting toxicities (DLT).

Phase II expansion phase The objective of the Phase II expansion cohort is to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows:

   1. Received at least 2 prior lines of therapy
   2. Transplant ineligible patients allowed assuming they meet criterion a.
   3. Patients who received prior chimeric antigen receptor modified T-cells (CAR-T) cell therapy or are considered ineligible for CAR-T therapy per the investigator's discretion
   4. FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL
2. Patients must be at least 18 years of age
3. Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.

Exclusion Criteria:

1. Central Nervous System (CNS) lymphoma
2. Time between previous treatment and first dose of study treatment (rituximab):

   1. Allogeneic hematopoietic stem cell transplantation (HSCT) \< 6 months prior to study treatment
   2. Autologous HSCT \< 3 months prior to study treatment
   3. CAR-T \< 2 months prior to study treatment
Persantin Preceding Elective PCI

In this study the investigators will investigate whether a short pretreatment (3-7 days) with dipyridamole 200mg twice daily will protect patients against myocardial injury sustained during an elective dotter operation of the coronary arteries (PCI).

The investigators hypothesize that dipyridamole can reduce myocardial injury sustained during elective PCI.

Rationale:

In elective PCI (percutaneous coronary intervention) up to 40% of the patients show an asymptomatic rise in myonecrosis marker troponin-I. This release of troponin-I has been found to represent irreversible myocardial injury and has been related to an increased risk of restenosis and even long-term mortality. Dipyridamole has been proven to induce protection against ischemia reperfusion injury and to reduce risk of cardiovascular death or event in secondary prevention after TIA or CVA.

Objective:

To test the hypothesis that dipyridamole improves tolerance to ischemia reperfusion injury in patients undergoing elective PCI.

Study design:

Double-blind placebo controlled intervention study

Study population:

Patients undergoing elective PCI

Intervention:

pretreatment with dipyridamole (Persantin Retard) 2dd 200mg or placebo.

Main study parameters:

Periprocedural troponin-I release measured 8 hours after PCI.

Bioequivalence study:

before the start of th clinical trial we will perform a bioequivalent study to test whether our study medication (blinded by recapsuling) equals original dipyridamole capsules. 6 Healthy volunteers in a cross-over randomised design will take original dipyridamole 200 mg SR and recapsuled dipyridamole 200mg SR (prepared by the department of pharmacy of the RUNMC). Plasma dipyridamole concentration will be measured frequently and at baseline and 1 and 3 hours after administration of dipyridamole nucleoside transport inhibitions of erythrocytes will be measured, to assess drug activity.

The clinical trial will only be initialized after conformation of bioequivalence of the study medication to the original dipyridamole.

Eligibility Criteria:
Inclusion Criteria:

* Patients accepted for elective single, native vessel (left anterior descending, right coronary artery or ramus circumflexus (LAD, RCA or RCX)) PCI in the RUNMC
* Troponin-I \< 0,20 mmol/L at screening
* Signed Informed consent

Exclusion Criteria:

* unstable angina
* recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
* 3-Vessel disease as seen on coronary angiogram
* Stenotic lesion in main stem as seen on coronary angiogram
* CABG in medical history
* asthma (recurrent episodes of dyspnoea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
* Treatment with insulin
* Use of prescribed oral anticoagulants (coumarin derivates)
* Use of oral corticosteroids
* Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride)
* Use of heparin or low molecular weight heparin
* Use of metformin
* Use of dipyridamole
* Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID's)
A Study of HIV in Newly Infected Individuals

The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients.

Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.

This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials.

This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).

Part A only:

* Previous enrollment in infected-participants cohort of HIVNET D01.

Part B only:

* Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
* Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.

Prior Medication:

Excluded:

* Participation in a HIVNET HIV vaccine trial.
Comparison Between Glandular Urethral Disassembly Versus Tubularized Incised Plate for Primary Distal Hypospadius Repair

To compare Glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius Repair

Aim of study to compare glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius Repair

Eligibility Criteria:
Inclusion Criteria:

* Primary Distal Hypospadius

Exclusion Criteria:

* secondary Distal Hypospadius Recurrent Hypospadius
Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients who have had a history of bronchial asthma for at least 6 months
* FEV1 \>60% of predicted for at least 24 h
* Patients who are hyperresponsive to methacholine and to AMP
* Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Patients suffering from COPD and/or other relevant lung diseases except asthma
* Current smokers and ex-smokers both with ≥10 pack years
Technology Assisted Stepped Collaborative Care Intervention

This study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education information.

End-stage renal disease patients on hemodialysis experience substantial symptom burden with fatigue, pain and depression among the most debilitating and existing as symptom clusters. These symptom clusters can exacerbate one another, and are independent and strong predictors of poor health-related quality of life in hemodialysis patients. This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. undergoing thrice-weekly maintenance hemodialysis for \> 3 months
3. English speaking
4. able to provide informed consent
5. no evidence of thought disorder, delusions or active suicidal ideation

Exclusion Criteria:

1. thought disorder, delusions or active suicidal ideation
2. active substance abuse
3. too ill or cognitively impaired to participate based on clinicians' judgment
4. anticipated life expectancy of less than 1 year
5. unable or unwilling to adhere to study protocol
6. participating in another clinical trial or taking an investigational drug
7. scheduled for living donor kidney transplant within next 6 months
8. relocating to another dialysis unit within 6 months