cyrilzakka/clinical-trials huggingface dataset:
A Study of EMB-02 in Participants With Advanced Solid Tumors

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.

This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D\[s\]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent.
* Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
* Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. \> 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
* Archival tumor samples available for retrospective analysis or biopsy will be taken.
* ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy \> 3 Months
* Adequate organ function to participate in the trial.
* Recovery from adverse events (AEs) related to prior anticancer therapy.
* Highly effective contraception

Exclusion Criteria:

* Patients who have active autoimmune disease or history of autoimmune disease
* History of severe irAE.
* History of severe allergic reactions
* Use of systemic corticosteroids.
* Symptomatic central nervous system metastases.
* Patients with cardiac dysfunction
* Uncontrolled diabetes mellitus with hemoglobin A1c \> 8% (via medical history)
* Prior treatment with a LAG-3 inhibitor
* Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
* Prior organ or stem cell/bone marrow transplant.
* Concurrent malignancy \< 5 years prior to entry.
* Patients with active infections.
* Major surgery \< 4 weeks or minor surgery \< 2 weeks prior to study treatment
* Live virus vaccines \< 30 days prior to screening
* Pregnant or breast-feeding females
* Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
* Any other serious underlying medical conditions
* Abuse on alcohol, cannabis- derived products or other drugs
The Japan-Combined Treatment With Olmesartan and a Calcium Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study (J-CORE)

The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and reducing target organ damage in Japanese hypertensive patients: Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics.

Renin-angiotensin (RA) inhibitors have been demonstrated to be the most effective drugs for reducing subclinical target organ damage in hypertensive patients. In several patients, however, BP control is not sufficiently achieved by RA inhibitors alone, and a combination of two drugs is frequently required. It is unclear whether a combination of RA inhibitors and diuretics or CCB is more effective in reducing hypertensive target organ damage. Control of central BP has been shown to be more effective than peripheral BP in predicting cardiovascular events and target organ damage associated with hypertension. The J-CORE study is active controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (PROBE) design study. The ARB plus CCB combination therapy group is administered olmesartan 20 mg/day and azelnidipine 16 mg/day and the ARB plus diuretics combination therapy group receives olmesartan 20 mg/day and hydrochlorothiazide (HCTZ) 12.5 mg/day. At least 100 patients will be enrolled in each group and the follow up duration will be 24 weeks. The primary endpoint is to compare the changes in the central aortic BP and the ambulatory BP between the two groups. The secondary endpoint is to compare the changes in office BP, home BP, and hypertensive target organ damage between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive outpatients aged 30 years or older, and less than 85 years (at the time of informed consent), regardless of sex
* Office systolic BP/diastolic BP \> 140/90 mmHg in a sitting position even if on treatment with olmesartan 20 mg/day for 3 months.

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* History of myocardial infarction or cerebrovascular accidents within 6 months prior to the screening
* Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) done within 6 months of screening or scheduled
* Current treatment for congestive cardiac failure (New York Heart Association \[NYHA\] functional class II or severer) or ejection fraction \<40%
* Atrial fibrillation or atrial flutter
* Renal dysfunction (serum creatinine ≥2 mg/dl)
* Hepatic dysfunction (AST and/or ALT ≥100 IU/l)
Effect of Exercise and Training on Fat Oxidation During Overfeeding - the FeedEX Study

Rationale: Body weight is not well regulated in all individuals. In an obesogenic environment, where overeating is common, some individuals are more prone to weight gain and therefore overweight than others. Yet, the reasons behind this are unclear. "Resistant" individuals often have higher physical activity levels (PALs). It seems that - at higher levels of physical activity and therefore energy expenditure - satiety signals are more precisely regulated, making one better at matching energy intake with expenditure. In other words, active people may not overeat where sedentary people would. However, this does not explain the differences in weight gain observed when subjects all have to overeat (imposed overfeeding). It could be that active people are better able to cope metabolically with the extra calories because of already higher levels of carbohydrate and fat oxidation compared to their inactive counterparts.

Objectives: 1/ To study the effects of overfeeding (normal diet composition) on substrate balance and oxidation and more specifically fat balance and oxidation; 2/ to study the effects of exercise and training on fat oxidation during overfeeding (normal diet composition).

Study design: This controlled intervention study will follow a cross-over design. Each subject will spend 5 nights and 4 days in a respiration chamber on two occasions, separated by a 10-week training period.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians
* Male
* Healthy
* 18-30 years
* BMI 21-27.5 kg.m-2
* Sedentary lifestyle: the following serve as (non-strict) guidelines: "Low category of activity" according to the short version of the International Physical Activity Questionnaire (IPAQ); VO2max (ml.kg-1.min-1) below: 45 - AGE (yrs) / 3 corresponding to a fitness category below "fair" (i.e. "poor" or "very poor") as defined by Schvartz and Reibold. For example for an 18 year-old male, VO2max below 39 ml.kg-1.min-1.
* Stable body weight (\<5% change in the last 6 months)

Exclusion Criteria:

* Following a (weight-loss) diet
* Using medications
* Smoking
* Consuming more than 3 units of alcohol per day
* Diagnosed with any chronic diseases known to affect energy metabolism (intake/expenditure) such as diabetes, cardiovascular disease, cancer, or thyroid disease.
* Trained or regularly physically active (according to the IPAQ)
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Adults 40-85 years of age
* Diagnosis of painful osteonecrosis of the knee within the last month.

Exclusion Criteria:

* Intravenous (iv) bisphosphonates within the last 2 years.
* Abnormal thyroid, kidney or liver function.
* Abnormal blood calcium or alkaline phosphatase levels.

Other protocol-defined inclusion/exclusion criteria may apply
Steroid Nasal Irrigation for Flavor Evaluation and Detection Study

The purpose of this research study is to examine the efficacy of a 12-week smell training intervention for participants with olfactory dysfunction following an infection of the upper respiratory tract.

Olfactory dysfunction affects up to fifteen percent of the general population and can cause significant psychosocial distress including decreased appetite, reduced self-hygiene, and mood disturbances.

This study aims to study the efficacy of smell training for patients with olfactory dysfunction following a viral upper respiratory tract infection. Eligible participants will complete a 30-day course of budesonide nasal saline irrigation. Participants who do not show improvement in their olfaction based on composite smell and taste tests will be eligible to receive a baseline resting-state fMRI (rs-fMRI) and complete a 12-week smell training intervention program. Smell training involves participants smelling 4 odors (phenyl ethyl alcohol, eucalyptus, lemon, and eugenol) twice a day for 12 weeks. Following completion of smell training, participants will undergo repeat smell and taste tests as well as rs-fMRI to ascertain the efficacy of smell training.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70
* Anosmia or hyposmia (UPSIT \<34 (male), UPSIT \<34 (female); Sniffin' Sticks threshold below 5.5)

Exclusion Criteria:

* Inability to understand English
* Current smoker or history of smoking within the past 6 months
* Current nasal polyps
* Exposure to head and or/neck radiation
* Exposure to chemotherapy
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.

Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
* Grade K-8
* Age 5-14 at time of enrollment
* Consent of student, parent and school
Combination of Sotyktu and Enstilar for Plaque Psoriasis

combination deucravacitinib and enstilar foam

30 adult patients with moderate to severe plaque psoriasis will be given Deucravacitinib 6mg QD for the first 8 weeks of the study.

At week 8:

Subjects who do not meet PASI 25 at week 8 will be discontinued from the study as non-responders.

Subjects who achieve ≥PASI 75 at week 8 will remain enrolled and continue Deucravacitinib 6mg QD monotherapy through week 24.

Subjects who achieved between PASI 25-74 response will receive 4 weeks of Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% applied QD in addition to continuing Deucravacitinib 6mg QD.

At week 12, (after 4 consecutive weeks of Enstilar), subjects in the PASI 25-74 group, will discontinue Enstilar QD and continue Deucravacitinib as monotherapy through week 24.

Subjects will return at week 28 for safety follow evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type psoriasis
3. Moderate to severe plaque type psoriasis as defined at baseline by:

   * BSA affected by plaque-type psoriasis of 10% or greater
   * PGA score of 3 or greater
   * PASI ≥ 12.
4. Able and willing to give written informed consent prior to performance of any study-related procedures Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.

Exclusion Criteria:

1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
3. Use of oral systemic medications or PUVA phototherapy for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
4. Prior use of biologics within the following periods:

   * Etanercept - 4 weeks
   * Adalimumab or certolizumab pegol - 8 weeks
   * IL-17 antagonists - 16 weeks
   * Ustekinumab or IL-23 pathway inhibitors - 24 weeks
   * Other biologics - 5 half-lives
5. Patient used topical therapies or UVB phototherapy to treat psoriasis within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp

Observational, descriptive, retrospective, multicenter study to evaluate the safety of the treatment with Sebryl® and / or Sebryl Plus® in the management of seborrheic dermatitis and psoriasis of the scalp in routine medical practice.

The objective of this study is to evaluate the frequency and intensity of adverse events presented during treatment with Sebryl® and / or Sebryl Plus® for the management of seborrheic dermatitis and psoriasis of the scalp. The sample will be at convenience. The files of the patients who have received treatment with Sebryl® and / or Sebryl Plus® in the last 5 years (2016 to 2021) will be chosen.

The researchers or the personnel designated by them will capture the information recorded by the treating physicians in the clinical file, sociodemographic, clinical and safety data that were presented after the prescription of Sebryl® and / or Sebryl Plus®.

Eligibility Criteria:
Inclusion Criteria:

* Any sex.
* Treatment with Sebryl® and / or Sebryl Plus® documented, for at least 2 consultations.
* That the patient has been questioned about possible adverse events

Exclusion Criteria:

* That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.
Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression

The aim of this randomized double-blinded placebo-controlled phase 2 study is to determine efficacy of preoperative treatment with interferon-alfa2a in patients with pMMR colon cancer on perioperative immune suppression and infiltration of lymphocytes in the primary tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years of age.
* Patients diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy.
* ASA class I-III (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

* Patients with childbearing potential without a negative pregnancy test before initiating study drug and / or non-acceptance to the use of contraceptive methods \*
* ECOG score function\> / = 3
* Current liver or renal disease.
* Severe heart disease
* Previous depression diagnosed by a psychiatrist or in treatment with antidepressant
* Autoimmune disease.
* Uncontrolled thyroid disease.
* Patients who are or have recently (within 6 months) received treatment with immunosuppressive agents other than corticosteroid treatment.
* Epilepsy and / or other serious CNS disorders.
* Patients that have undergone major surgery within one month before planned colon resection.
* Known hypersensitivity to recombinant interferon or auxiliary products of Pegasys®.

  * Spiral, pill, implant, transdermal patch, vaginal ring or depot injection. Sterile / infertile subjects are exempt from the use of contraception. To be considered sterile or infertile must generally be surgical sterilization (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months prior to study enrolment.
Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain

This study examines the effect of a 12-week intervention of physiotherapy with integrated Virtual Reality (VR) on 120 patients with complex chronic low back pain. Patients in the intervention group will receive physiotherapy with integrated VR, while patients in the control group will receive physiotherapy as usual. The (cost-)effectiveness of this intervention will be investigated at 3 months and 12 months follow-up.

Rationale: Physiotherapy, mainly consisting of exercise therapy and patient education, is a first-choice primary care treatment for patients with chronic low back pain (LBP), but unfortunately, especially patients with severe disability and pain demonstrate poor outcomes. Therapeutic VR is considered a potential breakthrough for LBP patients in general and for our complex group of patients with severe disability and pain in particular, as it specifically targets the identified limitations of usual physiotherapy. Therefore, a personalised, VR-integrated physiotherapy intervention, tailored to specific patient characteristics, is expected to result in larger improvements in physical functioning and pain, and more favourable cost-effectiveness, compared to usual physiotherapy.

Objective: The primary objective is to investigate whether a personalised, physiotherapy intervention with integrated therapeutic virtual reality (VR) is (cost-)effective at 3 months and 12 months follow-up, compared to usual physiotherapy, in a subgroup of patients with complex chronic low back pain (LBP) and severe disability and pain.

Study design: Cluster randomised controlled trial.

Study population: 120 chronic LBP patients with combination of severe disability and severe pain, consulting a physiotherapist in primary care.

Intervention: The experimental intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by research partners (i.e. Reducept and SyncVR) will be integrated into physiotherapy based on the recommendations of the LBP guidelines. The control intervention will be physiotherapy as usual.

Main study parameters/endpoints: Physical functioning (primary outcome), in addition to pain and a minimal set of other secondary clinical, adherence-related, psychological and economic measures, at baseline and 1, 3 and 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* LBP \> 3 months as reason to visit physiotherapist
* absence of 'red flags' or signs of specific LBP
* combination of severe disability (Oswestry Disability Index (ODI) score ≥ 30) and severe pain (numeric rating score (NRS) ≥ 5)
* age 18-80 years
* provides informed consent.

Exclusion Criteria:

* severe (physical or mental) comorbidity that will substantially hinder the physiotherapy
* planned diagnostic or invasive therapeutic procedure (e.g. injection, nerve block or operation) for LBP in next three months
* no comprehension of Dutch language
* inability to use VR (e.g. epilepsy, open wounds on face or severe visual impairment)
* no email-address and Wi-Fi
SET-to-Meet; Pilot Testing of a Nurse-led Intervention

While interdisciplinary family meetings are evidence-based and part of usual care, this study seeks to test a novel set of implementation strategies (the SET-to-Meet intervention) to improve adherence to best practice guidelines for interdisciplinary family meetings. SET stands for Screen-Engage-Track; SET-to Meet is a nurse-led, team based intervention to ensure routine interdisciplinary family meetings are held on behalf of incapacitated, critically-ill patients in ICUs. This study is a feasibility and acceptability pilot test of the intervention.

The intervention components are: a protocol for interdisciplinary family meetings that is tailored to the individual ICU unit and steps in the SET-to-Meet process: 1.) Screening of patients on admission to determine if patient meets criteria for a family meeting; 2.) proactively Engaging family members to inform them about the unit's protocol for family meetings and to find out who from the family might attend the meeting; and Tracking the progress of setting up the meeting (identifying the patient during ICU team rounds as a patient meeting criteria for a family meeting; discussing setting up the meeting with the ICU team; scheduling the meeting and communicating details to attendees.)

Implementation of the intervention includes: 1.) Working with the site ICU physician and nursing leadership to tailor the SET-to-meet protocol and tracking tool for family meetings, ensuring they are customized for the unit workflow and staffing model, and 2.) Providing on-line training and 2 weeks of on-site coaching to ICU nursing staff, care management/social work staff, and intensivists (MD and APP) in the use of the tailored protocol and tracking tool.

Feasibility and acceptability will be assessed by percentage of staff completing training, adherence to elements of the intervention, and number of patients meeting enrollment criteria. Acceptability will be assessed via focus groups and a survey testing satisfaction with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients: Individuals ≥18 year of age, admitted to the ICU for intensive care services at one of the 3 pilot sites during the pilot testing phase.
* Pilot site clinicians: nurses, care managers, social workers, and physicians who are employed/provide services in the pilot site.

Exclusion Criteria:

* Patient Exclusion Criteria : Those individuals \< 18 years of age, incarcerated, or admitted for reasons other than receipt of intensive care services (e.g. boarders).
* Pilot Site Clinicians Exclusion Criteria: none
Non-pharmacological Pain Management After Surgery

The purpose of this study is to test the impact of a bundled NOHARM Conversation Guide with clinical decision support intervention embedded within an Electronic Health Record (EHR) on pain and function 3 months following surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age and older.
* Must be undergoing qualifying surgeries at participating sites.
* Patients under 18 years of age.

Exclusion Criteria:

- Patients under 18 years of age.