cyrilzakka/clinical-trials huggingface dataset:
Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant

This clinical trial studies the use of early oral supplementation in improving nutritional status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional status in participants undergoing hematopoietic stem cell transplant has been linked to decreased outcomes such as increased length of hospital stay and increased time to engraftment (an important milestone in transplant recovery). Early oral supplementation may increase nutritional status and help to promote a positive outcome in participants undergoing transplant.

PRIMARY OBJECTIVES:

I. To determine if early oral supplementation improves nutritional status, decreases length of hospital stay, and shortens time to engraftment of hematopoietic stem cell transplant (HSCT) participants.

SECONDARY OBJECTIVES:

I. Serum albumin, serum 25-hydroxy vitamin D, and the degree of mucositis, as scored by the National Cancer Institute's Common Toxicity Criteria (NCI-CTC), a validated and widely accepted scale used for rating mucositis. The purpose of our secondary aims is to observe a potential correlation between the retrospective and prospective groups, as well as assess the need for future research based on these correlations.

OUTLINE:

Participants receive Boost Plus orally (PO) twice daily (BID) or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO once daily (QD) as an alternative.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing an autologous or reduced intensity conditioning (RIC) allogeneic HSCT
* A serum albumin greater than or equal to 2.5 g/dL
* Able to understand and sign consent

Exclusion Criteria:

* Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease
High Dose BAYA1040_Nifedipine: a Dose-comparative Study

This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.


Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Outpatient with essential hypertension
* Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug

Exclusion Criteria:

* Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
* Patients with secondary hypertension or hypertensive emergency
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
* Fasting plasma glucose: 126 - 240 mg/dL
* Hemoglobin A1c: 6 - 10%
* Estimated CrCl ≥ 60 mL/min
* ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN
* Stable and well controlled hypertension and/or dyslipidemia
* Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks

Exclusion Criteria:

* Women of childbearing potential
* Symptomatic diabetes with polyuria and/or polydipsia
* History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
* History of renal disease including diabetic nephropathy
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency

The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Must be of legal age and competent
* Age: \>18 and \<60 years old
* Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study

Exclusion Criteria:

* Alcohol consumption \>21 units per week
* Malignant disease
* Pregnancy
* Magnetic implants or material in the body
* Claustrophobia
* BMI \>30
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

Controls are matched on age, gender and BMI

Inclusion Criteria:

* Written informed consent
* Must be of legal age and competent

Exclusion Criteria:

* Alcohol consumption \>21 units per week
* Malignant disease
* Pregnancy
* Magnetic implants or material in the body
* Claustrophobia
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial
Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors

Preventing or reducing obesity is one factor that has been hailed as a way to improve quality of life, reduce recurrence, and increase survival rates among breast cancer survivors. An experienced team of multi-disciplinary researchers has developed an innovative and unique approach to encourage enhanced nutrition and exercise behaviors in this population using principles of behavioral economics. In particular, the use of social norms or exemplars has been shown in other applications to be effective, and if successful in this population could be inexpensively scaled up for widespread adoption. The proposed pilot study develops a system of text messages for social/mobile media that will provide ongoing reinforcement of desired behavior in breast cancer survivors. These messages would focus on achieving compliance with the expert-developed nutrition and exercise recommendations of the American Cancer Society. In the main study, 310 breast cancer survivors will be randomly placed in intervention and control groups for the 12 week study. Behavior change will be measured using established measures of self-reported behavior. In a sub-study, 60 of the breast cancer survivor participants will also provide blood and urine samples so changes in biomarkers can be assessed. The impact of the study will be measured by biomarkers and self-reported survey responses.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age: 20-75 years old
* No current pregnancy or lactation
* Was diagnosed with Stage 0-IIIB disease and completed all local and systemic therapy (including Herceptin) at least 3 months prior to entry. Women can be on or off anti-hormone therapy.
* Ambulatory
* Willing to be randomized

Exclusion Criteria:

* Current participation in other treatment (chemo/radiotherapy) clinical trials
* Instructed by doctor not to exercise
* Cannot read English
* Not able to receive text messages
Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.


Eligibility Criteria:
Inclusion Criteria:

* asymptomatically infected individuals with any P. falciparum parasite density

Exclusion Criteria:

* age \< 15 years or \> 25 years
* malaria parasite density ≥ 10,000 parasites/µL
* clinical symptoms indicating severe malaria
* axillary temperature ≥ 37.5°C
* Body Mass Index (BMI) below 18 or above 32 kg/m2
* haemoglobin concentration below 11 g/dL
* taken ivermectin in the last three months
* Loa loa as assessed by questionnaire, clinical examination and parasitological assessments
* for women: pregnancy or lactation
* known hypersensitivity to AL or IVM
* history and/or symptoms indicating chronic illness
* current use of tuberculosis or anti-retroviral medication
* unable to give written informed consent
* unwillingness to participate in two membrane feeding assays
* travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.
* history of cardiovascular disease.
* taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
* known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
* taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
Application of 68Ga-Pentixafor PET/CT for Thymoma

Chemokine receptor CXCR4 was expressed in T cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of thymoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, distinguish evaluation for thymoma.

Thymoma is 1 rare type of tumor developed on the thymic epithelium; patients with thymoma also might have myasthenia gravis (MG). Because of the scarcity and complexity of MG-associated thymoma, its pathogenesis and etiology still remain unclear nowadays. The expression of C-X-C chemokine receptor type 4 (CXCR4) is absent or low in most healthy tissues but highly expressed in various types of tumors. CXCR4 might contribute to the clinical cancer progression, and CXCR4 could be a valuable prognostic biomarker in the therapy of MG-associated thymoma.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed untreated thymoma patients
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may
* significantly interfere with study compliance.
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia

The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by chemotherapy in patients with acute leukemia (AL).

Thrombocytopenia is a common and potentially fatal complication of chemotherapy and hematopoietic stem cell transplantation. Owing to the short storage time and increased demand of platelets from unrelated donors, a constant shortage in the supply of platelets has become an important medical and society challenge. Therefore, investigation of alternative sources of platelets would be beneficial.

Hematopoietic stem cells (HSCs) can be used to generate functional megakaryocytic progenitors (MPs), megakaryocytes, and platelets on a large scale. Functional MPs and platelets have successfully been produced in vitro from CD34+ hematopoietic cells from bone marrow, cord blood, and peripheral blood. Several studies have reported that transplantation of in vitro auto-producing MPs can promote platelet recovery after high-dose therapy and HSC transplantation.

Umbilical cord blood is an abundant source of HSCs. In vitro large scale production of MPs from cord blood could represent an effective platelet substitute. Theoretically, the additional transplantation of ex vivo generated progenitor and post-progenitor cells might lead to the production of sufficient numbers of mature functional cells within a few days after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* age：14-65 years
* achieve complete remission of acute leukemia
* the first course of consolidation chemotherapy
* ECOG grades 0 or 1
* expected survival time ≥ three months
* Subjects (or their legally acceptable representatives) must have signed an informed consent document.

Exclusion Criteria:

* cardiac dysfunction (particularly congestive heart failure), hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal), renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Biomarkers for the Early Identification of Sepsis in the Emergency Department

Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis.

Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection.

Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.

Eligibility Criteria:
Inclusion Criteria:

* patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam

Exclusion Criteria:

* patient minor under 18-year
* pregnancy
* anticipated no follow-up possible (homeless...)
* Refusal to participate
* patient under curators, prisoner
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
* Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Cisplatin-ineligible participants will be defined by any one of the following criteria:

  i) Impaired renal function (glomerular filtration rate \[GFR\] ≥ 30 but \< 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing loss (assessed per local SOC).

iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy.

* Documented Left Ventricular Ejection Fraction (LVEF) more than 45%

Exclusion Criteria:

* Clinical evidence of ≥ N2 or metastatic bladder cancer
* Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment.
* Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC
* History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event
* Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias)

Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemia

Phase IV, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by P. aeruginosa (BSI-PA).

The project is designed to determine the optimal duration of antibiotic treatment for Pseudomonas aeruginosa bacteremia, by comparing an adequate antibiotic treatment regimen of 7 days (experimental arm) with another of 14 days (control arm). The evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives.

Active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose.

Clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment.

This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 90 days after the first positive blood culture.

Eligibility Criteria:
Main inclusion criteria:

* Adult patients with diagnosis of BSI-PA who have received 6 days (+/- 1) of active antibiotic treatment from the date of extraction of the first positive blood culture and until the moment of randomization.
* Informed consent signed.

Main exclusion criteria:

* Bacteremia source not adequately controlled at least 72h before randomization.
* Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment more than 7 days
* Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment.
* Bacteremic pneumonia in severely immunosuppressed patients
* Bacteremia of any origin in patients with severe neutropenia (\<500 cells / mm3) at the time of randomization.
Risdiplam in Patients With Spinal Muscular Atrophy Previously Treated With Nusinersen

Risdiplam Exchange (RISE) is a study of spinal muscular atrophy (SMA) patients who crossover to 36 months of open-label risdiplam monotherapy following a comparable period of nusinersen treatment. The schedule of assessments (SOAs) carry over seamlessly for the cohort from studies done while treated with nusinersen and continue to track the most informative outcomes from that trial (e.g. nine hole peg test and grip strength), while adding the Box and Block Test (BBT) as an additional measure of upper limb endurance and function.

Risdiplam is an orally bioavailable small molecule that distributes into the central nervous system (CNS) and peripheral tissues where it modifies SMN2 pre-mRNA splicing and increases tissue SMN protein levels. It was approved by the U.S. Food and Drug Administration for all SMA patients older than 2 months of age in August 2020.

Clinical trial data prompted us to consider risdiplam a reasonable alternative to nusinersen administered intrathecally or by subcutaneous intrathecal catheter (SIC) for patients with more advanced SMA. Considered within this clinical context, risdiplam presents a significant advantage by eliminating the risks of mechanical failure, intrathecal bleeding, and CNS infection associated with the SIC device. The schedule of assessments (SOAs) used in this cohort during the previous three-year period as part of a nusinersen study provide us with an established framework for data collection. Thus, the overall clinical experience with risdiplam as compared to nusinersen can be assessed using a prospective, crossover design in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Biallelic SMN1 deletions
* 3 or 4 copies of SMN2
* Prior treatment with nusinersen for a minimum of 22 months

Exclusion Criteria:

* Prior treatment with SMN gene replacement therapy
* Prior exposure to another investigational agent.
* Confounding neuromuscular disorder other than SMA
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.

This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.

Eligibility Criteria:
Inclusion Criteria:

1. Male 19-50 years of age.
2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
3. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
4. Medically healthy with no clinically significant medical history.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
4. Plasma donation within a month prior to the first dose of study drug.
5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).